Avigan (Favipiravir) Antiviral Description
Avigan (Favipiravir) (T-705) (Reeqonus) Tablet is a pyrazinecarboxamide derivative with activity against RNA viruses. Host enzymes convert Favipiravir to the ribofuranosyltriphosphate derivative and selectively inhibit the influenza viral RNA-dependent RNA polymerase.
Avigan (Favipiravir) was approved for manufacture and sale in Japan in 2014 as an influenza antiviral. However, Avigan is considered for use only when there is an outbreak of novel or re-emerging influenza virus infections.
Favipiravir-based drugs are sold worldwide, such as Avigan, FabiFlu, Avifavir, Favijaj, Ciplenza, FluGuard, Avifavir, Coronavir, and Reeqonus in Canada.
Avigan undergoes an intracellular phosphoribosylation to be an active form, favipiravir-RTP (favipiravir ribofuranosyl-5′-triphosphate) is recognized as a substrate RdRp and inhibits the RNA polymerase activity, and is a pyrazinecarboxamide derivative. Favipiravir-RTP is a nucleoside analogue. It mimics both guanosine and adenosine for the viral RdRP.
Since the catalytic domain of RdRp is conserved among various types of RNA viruses, this mechanism of action underpins a broader spectrum of antiviral activities of favipiravir.
The active favipiravir-RTP selectively inhibits RNA polymerase and prevents replication of the viral genome. In addition, studies have shown that favipiravir-RTP is incorporated into a nascent RNA strand prevents RNA strand elongation and viral proliferation. Studies have also found that the presence of purine analogs can reduce favipiravir's antiviral activity, suggesting competition between favipiravir-RTP and purine nucleosides for RdRp binding.
Toyama Chemical Co., Ltd. discovered Avigan (favipiravir), which selectively inhibits RNA polymerase necessary for influenza virus replication. Due to this mechanism of action, it is expected that Avigan may potentially have an antiviral effect on the new coronavirus, SARS-CoV-2, because, like influenza viruses, coronaviruses are single-stranded RNA viruses that also depend on viral RNA polymerase.
Glenmark Pharmaceuticals confirmed on September 15, 2021, a prospective, open-label, multicentre, single-arm phase 4 study of Favipiravir showed that fever resolution was four days, while the time for a clinical cure was seven days. And, no new safety signals or concerns with the use of Favipiravir, and already-known side effects were found to be mild.
Appili Therapeutics Inc. announced that the Phase 3 PRESECO clinical trial evaluating oral antiviral Avigan (Reeqonus) (favipiravir) for the treatment of mild-to-moderate COVID-19 did not achieve statistical significance on the primary endpoint of time to sustained clinical recovery.
Favipiravir Accession Number: DB12466; Chemical Formula: C5H4FN3O2; ATC code: J05AX27
Avigan (Favipiravir) Antiviral History
On September 23, 2020, Fujifilm Toyama Chemical Co. announced a small phase III trial in Japan, which began in March 2020, was now complete. It intends to apply the medication to be approved for treating coronavirus patients after trials showed it could shorten recovery time. In this study, the median value of primary endpoints, using 156 individuals as analysis targets, was 11.9 days for the Avigan group and 14.7 days for the placebo group. FUJIFILM Toyama Chemical confirmed, with a statistically significant difference (p-value = 0.0136), that the administration of Avigan to COVID-19 patients with non-serious pneumonia demonstrates a shorter time to resolution. The adjusted hazard ratio*2 showed 1.593 (95% confidence interval of 1.024 – 2.479). No new safety concerns were noted in this trial.
Previously, Fujifilm signed a patent license agreement on its anti-influenza medication Avigan (favipiravir) Tablet with China's significant pharmaceutical Company Zhejiang Hisun Pharmaceutical in June 2016.
On June 1, 2020, Avifavir (Favipiravir) received a temporary registration certificate from the Ministry of Health of the Russian Federation, which has included Avifavir in its latest 7th edition of the prevention guidelines diagnosis, and treatment of new coronavirus infection COVID-19. Starting June 10, 2020, Avifavir was delivered to more than 50 Russian regions and Belarus and Kazakhstan.
Favipiravir-based drugs, such as Coronavir, have demonstrated efficacy in clinical trials held in the leading medical centers across Russia, involving patients with confirmed cases of COVID-19. The drugs disrupt the coronavirus's reproduction mechanisms, relieve symptoms, and halve the treatment period compared to standard therapy.
On July 13, 2020, Glenmark Pharmaceuticals announced that it would lower the price of its generic version of favipiravir, FabiFlu, to 75 rupees ($0.9983) per tablet. This indicates a treatment course with FabiFlu would require a patient to take 122 tablets over 14 days and will now cost 8,475 rupees ($112.80) per patient at the new price.
Glenmark reported results from a phase 3 trial on July 22, 2020, that showed numerical improvements for the primary efficacy endpoint with 28.6% faster viral clearance in the overall population as measured by the median time until cessation of oral shedding virus in the Favipiravir treatment arm. In addition, Glenmark's Favipiravir was well tolerated with no serious adverse events or fatalities in the Favipiravir-treated arm.
Stanford University is conducting a phase II trial of 120 patients with mild coronavirus symptoms in the USA. This study was last updated on July 27, 2020. And a separate phase II study in Massachusetts was last updated on September 9, 2020.
Avigan is not approved for distribution in the USA by the U.S. FDA.
FUJIFILM Toyama Chemical Co., Ltd. is located at 14-1, Kobayashi 2-Chome, Chuo-Ku, Tokyo 104-0031 Japan. The Drugbank Accession Number is DB12466.
Avigan (Favipiravir) Antiviral Indication
Avigan (favipiravir) (REEQONUS) is effective against a wide range of types and subtypes of influenza viruses, including strains resistant to existing anti-influenza drugs, says a study published by the US NIH.
On June 19, 2020, Glenmark Pharmaceutical became the first Company in India to receive restricted emergency use approval from India's drug regulator for FabiFlu®, making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19.
The mortality rate in the Favipiravir study group was approximately 30% less than the control group when used early in the treatment of a SARS=CoV-2 virus infection, reported the journal Nature on May 26, 2021.
Of note is that favipiravir shows antiviral activities against other RNA viruses such as arenaviruses, bunyaviruses, and filoviruses, all known to cause fatal hemorrhagic fever. These unique antiviral profiles will make Avigan a potentially promising drug for specifically untreatable RNA viral infections. The main advantages of favipiravir are that it is administered orally. Thus, it can be given in patients who are symptomatic but not ill enough to be hospitalized, stated a study published in September 2020.
Most COVID-19 patients (85%) have mild to moderate disease and can be treated at home; this drug could be used in many patients. As with any antiviral, it should be stressed that favipiravir should be administered early after the onset of symptoms to reduce viremia effectively. Its role in potentially shortening viral shedding could also have an epidemiological impact as it could reduce viral transmission at home and in the community.
Favipiravir has been investigated to treat life-threatening pathogens such as the Ebola virus and Lassa virus.
Avigan (Favipiravir) Antiviral Dosage
As an influenza antiviral drug approved for manufacture and sale in Japan, Avigan (Favipiravir) selectively inhibits RNA polymerase necessary for influenza virus replication.
The dosage of Avigan to treat COVID-19 disease patients is currently being evaluated in various clinical studies. For example, in a phase 2 study in Boston, Massachusetts, Aviagn tablets are being evaluated: on the first day, once for 1600 mg, twice a day; From the 2nd day to the 10th day, once for 600 mg, twice a day; maximum of ten days for oral administration of the drug.
However, reports indicate Avigan cannot be administered to expecting mothers or those who may become pregnant.
On September 2, 2020, a study from India found that the drug's side-effect profile also seems acceptable, with asymptomatic hyperuricemia and mild, reversible elevation in transaminases being the most frequently reported adverse effects. In the Indian trial, no special safety signal was elicited. However, it is teratogenic and must never be used in pregnant women.
The main disadvantage is a high pill burden, which works out to a loading dose of 18-tablets on the first day and then 8-tablets a day for the rest of the course.
Avigan (Favipiravir) Antiviral News
November 12, 2021 - “While we are disappointed by the topline results of the PRESECO trial, we remain steadfast in our belief that safe and effective oral antivirals are urgently needed for patients who are still struggling to overcome COVID-19,” said Dr. Armand Balboni, CEO, Appili Therapeutics.
November 5, 2021 - National Geographic published an article: How the rise of antivirals may change the course of the pandemic.
November 3, 2021 - The journal Nature published an article - In a bid to stave off looming disaster, scientists are trying to repurpose drugs used for malaria and other diseases, but infrastructure and recruitment challenges stymie progress.
October 28, 2021 - AiPharma owned Global Response Aid and Pharmax announced they have partnered to supply Avigan (Favipiravir) in the UAE. Favipiravir was added to the list of approved therapeutics in the Dubai Health Authority's National Guidelines for Clinical Management and Treatment of COVID-19 in June 2020.
October 14, 2021 - Appili Therapeutics (TSX: APLI) announced the closing of a Public Offering of $7,000,220. Dr. Armand Balboni, CEO, Appili Therapeutics, commented, "With the COVID-19 pandemic continuing to evolve, the need for at-home oral antivirals remains urgent. As Appili rapidly approaches the top-line readout from our Phase 3 PRESECO trial, which is evaluating the oral antiviral Avigan®/Reeqonus™ (favipiravir) for the treatment of mild-to-moderate COVID-19, this funding will support us as we move aggressively to deliver this critically needed medicine and hopefully change the trajectory of this pandemic."
September 29, 2021 - A spokesperson told The Pharmaceutical Journal that Keith Ridge, chief pharmaceutical officer for England, has taken on the role of senior responsible officer for oral antiviral deployment. The UK's Antivirals Taskforce was established by the Department of Health and Social Care in April 2021.
September 29, 2021 - Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) and AiPharma Global Holdings LLC announced a strategic alliance to advance the global development of Avigan® / Reeqonus™ (favipiravir).
September 23, 2021 - Appili Therapeutics Inc. announced it has completed enrollment in its global Phase 3 PRESECO trial evaluating oral Avigan®/Reeqonus™ (favipiravir) as a potential COVID-19 treatment. Appili expects to report top-line data from this trial in approximately 60 days.
September 20, 2021 - Appili Therapeutics Inc. announced it entered into an agreement with FUJIFILM Toyama Chemical Co., Ltd., that will provide funding support for its Phase 3 PRESECO (PREventing SEvere COVID-19) clinical trial. The new funding of $1,000,000 USD was secured from FFTC, one of the Company's partners in a global consortium focused on the worldwide development, commercialization, and distribution of Avigan®/Reeqonus™ (favipiravir) tablets for the potential treatment and prevention of COVID-19. The new funding will support various components of the recently expanded PRESECO trial, including study close-out activities as the Company prepares for database lock and top-line results.
September 17, 2021 - Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) announced it has completed patient enrollment in the viral shedding sub-study portion of its Phase 3 PRESECO (PREventing SEvere COVID-19) trial evaluating Avigan®/Reeqonus™ (favipiravir) as a potential oral antiviral COVID-19 treatment in the USA. The viral shedding sub-study is designed to identify COVID-19 variants in study patients and evaluate the direct antiviral effect of favipiravir against the SARS-CoV-2 virus, including recent and emerging variants.
September 16, 2021 - According to a document submitted to Japan's Patent Office in August 2021 and seen by Nikkei Asia, it cites a past patent filing by Toyama Chemical and academic papers arguing that the efficacy of favipiravir against the severe acute respiratory syndrome (SARS) virus has been demonstrated and that both SARS and SARS-CoV-2, the virus that causes COVID-19, belong to the same coronavirus family.
September 15, 2021 - Glenmark Pharmaceuticals announced the successful completion of its Post Marketing Surveillance phase 4 study on Favipiravir (FabiFlu®) in India. The study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 patients. A total of 1,083 patients were enrolled in the prospective, open-label, multicentre, single-arm study. Results showed no new safety signals or concerns with the use of Favipiravir. The time for fever resolution was 4 days, while the time for a clinical cure was 7 days.
September 7, 2021 - Reuters reported Japan had selected Fujifilm Holding Corp's antiviral favipiravir, known commercially as Avigan, to receive subsidies for clinical trials.
August 13, 2021 - Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) announced its financial and operational results for the first quarter of its fiscal year 2022, which ended on June 30, 2021; including completing an interim analysis of the ongoing Phase 3 PRESECO trial evaluating Avigan / Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19 and receiving a unanimous recommendation from the independent Data Safety and Monitoring Board to continue the study without modifications; Expanding the PRESECO to Latin America in June with the addition of several clinical research sites in Mexico and Brazil. Note: Appili entered into a $3.5 million convertible security funding agreement with Lind Global Fund II, LP, on August 9, 2021.
August 8, 2021 - Thailand's Department of Medical Services Public Health Ministry decided to administer Favipiravir to more groups of Covid-19 patients and is planning to stockpile 420 million tablets of the drug, reported local media.
August 2, 2021 - Local media reported that Thailand's National Health Security Office would purchase an additional 27 million tablets of favipiravir in 2021 and 2022 to treat Covid-19 patients.
July 30, 2021 - Dove Press published a study that included, 'According to other studies, favipiravir induces lethal mutations in RNA, resulting in a nonviable virulent phenotype. Favipiravir is a prodrug converted to favipiravir-RTP, an active form of ribofuranosyl-5-triphosphate that competes for polymerase active binding sites.32 Favipiravir is capable of inhibiting the RdRp enzyme of RNA viruses like influenza.'
July 12, 2021 - FDC Limited announced the launch of India's first oral suspension of Favipiravir – Favenza Oral Suspension, used to treat mild to moderate cases of COVID-19. This prescription-only solution is currently available at all retail, medical outlets, and hospital pharmacies across the country.
July 9, 2021 - Reuters reported Fujifilm Holdings Corp focuses on its drug ingredients business to drive future profits. The Company's new chief executive said, after issues with the Avigan antiviral drug for the treatment of COVID-19. On July 6, 2021, FUJIFILM Holdings Corporation President: Teiichi Goto has drawn up Fujifilm Group's "DX*1 (Digital Transformation) Vision" to promote DX further to provide products and services of even greater quality than ever before, thereby dramatically enhance the value the Group provides to customers as the Company continues to work toward solving social issues.'
July 7, 2021 - The Indonesian Food and Drug Supervisory Agency granted an emergency permit to use Avigan to treat COVID-19 patients.
June 24, 2021 - Appili Therapeutics Inc. announced in a press statement: "We are encouraged that an independent Data and Safety Monitoring Board has recommended continuation without modification of Appili's ongoing Phase 3 PRESECO trial evaluating Avigan® / Reeqonus™ (favipiravir). We look forward to the completion of the PRESECO trial and are hopeful that Avigan/Reeqonus will emerge as one of the first prescription oral medicine for newly diagnosed patients with COVID-19," commented Dr. Balboni.
June 17, 2021 - Appili Therapeutics Inc. has added several clinical research sites in Mexico and Brazil to its Phase 3 clinical trial evaluating Avigan® / Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19. The expansion into Mexico and Brazil will ensure timely completion of this pivotal trial and reaffirm favipiravir as one of the most advanced oral COVID-19 antiviral candidates in development, with top-line data expected in Q3 2021.
June 14, 2021 - Ireland-based AiPharma announced a production and distribution deal for China and the Russian Federation with FUJIFILM for its influenza antiviral drug Avigan® for COVID-19.
June 8, 2021 - Glenmark Pharmaceuticals announced interim data of 503 patients from its Post Marketing Surveillance study on Favipiravir (FabiFlu) in India. The time to fever resolution was seen on day 3, while two-third of the patients achieved clinical cure on day 7. The study commenced in July 2020 aimed to evaluate the safety and efficacy of Favipiravir in mild to moderate Covid-19 patients. A total of 1,083 patients have been enrolled in the prospective, open-label, multicenter, single-arm study. A total of 13 sites – both Government and private institutions – across Mumbai, Bangalore, Hyderabad, Nashik, Nagpur, and Trivandrum took part. Glenmark's interim data to the regulator reveals no new safety signals or concerns using Favipiravir and already-known side effects such as weakness, gastritis, diarrhea, vomiting, etc., which were found to be mild in nature. The time to fever resolution was seen on day 3, while two-third of the patients achieved clinical cure on day 7.
June 7, 2021 - India's Union health and family welfare ministry revised the Covid-19 treatment guidelines and removed the use of the antiviral drug favipiravir from its list of advised treatment.
May 27, 2021 - BMC published: Favipiravir for treating patients with COVID-19: a systematic review and meta-analysis. Conclusions - Favipiravir induces viral clearance by 7 days and contributes to clinical improvement within 14 days. The results indicated that favipiravir is strongly capable of treating COVID-19, especially in patients with the mild-to-moderate illness. However, additional well-designed studies, including examinations of the dose and duration of treatment, are crucial for reaching definitive conclusions.
May 26, 2021 - The journal Nature published a study: The efficacy and safety of Favipiravir in treatment of COVID-19: a systematic review and meta-analysis of clinical trials. Finding: The mortality rate in the Favipiravir group was approximately 30% less than the control group, but this finding was not statistically significant. Favipiravir possibly exerted no significant beneficial effect in the term of mortality in the general group of patients with mild to moderate COVID-19. We should consider that perhaps the use of antiviral once the patient has symptoms is too late, which would explain their low efficacy in the clinical setting.
May 22, 2021 - India-based Bharat Parenterals confirmed it received approval from the Drugs Controller General of India for favipiravir l00mg/ml oral suspension for treating COVID-19.
May 17, 2021 - Appili Therapeutics Inc. announced that an independent Data and Safety Monitoring Board had recommended continuation without modifying the ongoing Phase 3 PRESECO trial evaluating Avigan® / Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19.
May 10, 2021 - Vivimed Labs received India's approval to manufacture and market Favipiravir Tablet 200 mg and 400 mg for the Indian market.
May 4, 2021 - PTI reported India-based Bajaj Healthcare announced the launch of its antiviral Favipiravir tablets under the brand name 'Favijaj' to treat mild to moderate COVID-19 infections in India said in a BSE filing. The Company successfully developed the active pharmaceutical ingredient and formulated favipiravir through its own in-house R&D team.
April 21, 2021 - FUJIFILM Toyama Chemical Co., Ltd. announced a new phase III clinical trial in Japan concerning its anti-influenza drug Avigan® Tablet (Avigan; favipiravir), targeting patients infected with COVID-19. The trial is a double-blind, placebo-controlled clinical trial investigating the drug's efficacy and safety in patients with early-onset COVID-19 with risk factors for progression to severe symptoms.
April 19, 2021 - Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) announced that Dr. Armand Balboni would present at the fully virtual Bloom Burton & Co. Healthcare Investor Conference taking place on April 20 and 21, 2021.
April 12, 2021 - Philippines-based My Med Rx Plus Corporation announced it had placed orders for 1 million Favipiravir (Avigan) and 3 million tablets of Umifenovir (Arbidol) tablets to secure supplies for hospitals and patients.
March 31, 2021 - The journal Nature published a study: Safety and efficacy of favipiravir versus hydroxychloroquine in management of COVID-19: A randomized controlled trial. Finding: Favipiravir is a safe, effective alternative for hydroxychloroquine in mild or moderate COVID-19 infected patients.
March 24, 2021 - The Russian Direct Investment Fund and the ChemRar group of companies announce that they have received a registration certificate from the Indonesian Medicines and Foods Control Agency for the Avifavir antiviral (favipiravir). Registration of Avifavir in Indonesia was carried out according to an accelerated procedure based on data from an extended phase II-III clinical trial, which took place from April to September 2020, at 30 specialized centers throughout Russia with the participation of 460 patients.
March 17, 2021 – Appili Therapeutics Inc. announced that it would present at the fully virtual Inaugural Emerging Growth Virtual Conference, presented by M Vest LLC and Maxim Group LLC taking place on March 17th through 19th. In addition, Appili CEO Dr. Armand Balboni, M.D., Ph.D., will participate in a Fireside Chat on Friday, March 19th at 4:30 PM ET. Appili is developing a version of Avigan (Favipiravir) for use in Canada and the USA. "While we are encouraged by the early signals that favipiravir may be active against COVID-19, we realize that there is a duty to provide robust clinical data evaluating favipiravir as an early treatment option and prophylactic agent. Appili is honored to be a part of this world-class clinical program as we race to find options for the greatest public health threat of our lifetime."
March 9, 2021 - According to IQVIA data, Favipiravir posted total sales of Rs 424 crore from June to December 2020 in India.
February 21, 2021 - Kyodo News reported that Fujifilm Holdings Corp is considering restoring a clinical trial for its drug Avigan in treating COVID-19 patients. Details, including when the trial would start in Japan, have yet to be determined.
February 12, 2021 - Appili Therapeutics Inc. announced recent operational highlights include: Signing a collaboration, development, and supply agreement to create a global consortium with Dr. Reddy's Laboratories Ltd. and Global Response Aid for oral COVID-19 antiviral candidate favipiravir (REEQONUS); Working with partner DRL to support the filing of an application under Health Canada's interim order for favipiravir oral tablets (REEQONUS in Canada) on behalf of the global consortium; Dosing the first participant and activating over 50% of the planned sites in the U.S. for its Phase 3 PRESECO study evaluating favipiravir for the early treatment of mild-to-moderate COVID-19 infections; Receiving a 'No Objection Letter' from Health Canada to initiate the Phase 3 PEPCO study evaluating favipiravir for the prevention of COVID-19 in exposed individuals in the community setting.
January 28, 2021 - Appili Therapeutics Inc. announced that its Phase 3 PRESECO (PReventing SEvere COvid-19) clinical trial actively recruited participants in 12 out of 20 sites in the USA. Based on current forecasts, Appili believes it will reach the enrollment threshold required to provide an interim data readout by late March 2021. PRESECO evaluates favipiravir, an oral antiviral, in the early treatment of COVID-19 in the outpatient setting. The Company is also pursuing regulatory approvals to expand PRESECO into Mexico, Brazil, and Colombia.
January 27, 2021 - India-based Dr. Reddy's Laboratories Ltd. and Global Response Aid FZCO announced the termination of the Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID-19 patients in a hospital setting. The subgroup analysis of the low-risk (low NEWS Score at admission) study cohort (n=181) demonstrated a 3 day earlier discharge in the Avigan group compared to the placebo group (8 days vs. 11 days; p=0.0063) for time to hospital discharge secondary endpoint. Thus, during the initial interim analysis, the subgroup analysis data points towards the hypothesis with clinically significant insights from this study that an antiviral drug such as Avigan may be effective as part of early treatment initiation in COVID-19 patients and not effective in the late-stage hospital treatment for moderate and severe COVID-19 patients.
January 6, 2021 - The Lancet published a commentary: Understanding the pharmacokinetics of Favipiravir: Implications for treating influenza and COVID-19. Results from this study, as well as others, demonstrate a highly complex pharmacokinetic profile. The pharmacokinetics combined with mixed efficacy results suggest more studies are needed to understand dosing patients with favipiravir. This study provides more information about favipiravir and highlights the need to understand the pharmacokinetic/pharmacodynamic interface before we can begin optimizing dosing, particularly in patients with severe illness.
January 1, 2021 - Study: Role of favipiravir in the treatment of COVID-19. Conclusion: Considering the approved status, evidence on the safety, and key indicators of efficacy of favipiravir in COVID-19 from trials/registries in Russia, Japan, China, and Thailand, it appears to be useful management of COVID-19, particularly mild to moderate disease.
December 22, 2020 - Dr. Reddy's Laboratories Ltd., Appili Therapeutic, and Global Response Aid FZCO announced that Dr. Reddy's Canada had filed an application on behalf of the consortium for REEQONUS™ (favipiravir) Tablets for the acute treatment of mild to moderate COVID-19 adult patients under Health Canada's Interim Order Respecting the Importation, Sale, and Advertising of Drugs for Use concerning COVID-19. REEQONUS is also known as Avigan® (favipiravir) Tablets, developed by FUJIFILM Toyama Chemical Co., Ltd.
December 19, 2020 - According to the National Institute of Pharmacy and Food Health (OGYÉI), a new coronavirus drug-containing favipiravir, manufactured by the Hungarian pharmaceutical company Egis, has been approved, so it is expected to be used in the treatment of coronavirus patients from mid-January. The preparation is managed by the state health reserve and delivered to health care providers, writes MTI.
December 17, 2020 - Japanese authorities have found it difficult to conclude the effectiveness of antiviral drug Avigan in treating COVID-19 patients based on clinical testing results by its developer, FUJIFILM Toyama Chemical Co., Ltd. However, according to local media, the Pharmaceuticals and Medical Devices Agency's latest assessment will likely decide whether to approve the use of Avigan to treat COVID-19 in Japan.
December 14, 2020 - The Philippines Department of Health announced it had to tweak the Avigan clinical trial protocol against COVID-19 to get more participants. The anti-flu drug Avigan is among the off-label drugs being studied as a possible treatment for the new coronavirus disease. As of December 7, the study had a total of 16 participants.
December 11, 2020 - Professor Fehmi Tabak of Istanbul University's Cerrahpaşa Faculty of Medicine says favipiravir is one of the strongest currently available medicines against COVID-19. Still, people stopping intake based on rumors see their situation worsen. "The drug might have minor side effects on people with liver problems, but it does not have any side effect for COVID-19 patients without any underlying disease," he said.
December 10, 2020 - Nepal Health Research Council has decided to test antiviral medicine favipiravir on Covid-19 patients admitted to Kathmandu and Pokhara hospitals. The drug, administered under a phase-III trial, will be given to 600 patients with mild or moderate contagious disease symptoms. Favipiravir is being manufactured by Deurali-Janta Pharmaceuticals Pvt. Ltd in Nepal.
December 2, 2020 - Appili Therapeutics Inc. announced that investigators had dosed the first participant in its Phase 3 trial (referred to as the "PRESECO" clinical trial) evaluating oral Avigan® tablets (favipiravir) for the treatment of COVID-19. Appili expects to report early data from the PRESECO study in the first half of 2021. Appili is initially focusing the trial in the United States but may expand it to other areas of the world affected by COVID-19.
November 30, 2020 - The sovereign wealth fund of the Russian Federation and the ChemRar group of companies announce an increase in production of the first Russian drug against the new coronavirus infection, Avifavir. The production level is now 200,000 packs per month. Avifavir (favipiravir) is the first drug globally with the active ingredient favipiravir, registered to treat new coronavirus infections.
November 24, 2020 - Appili Therapeutics Inc. announced the initiation of its Phase 3 Post Exposure Prophylaxis for COVID-19 (PEPCO) study to evaluate Avigan® tablets (favipiravir) in the prevention of COVID-19. And Health Canada has provided a 'No Objection Letter (NOL)' for Appili's proposed study; the U.S. FDA accepted a submission of a protocol amendment to conduct the trial in the USA. This is the second Phase 3 study that Appili has announced to evaluate Avigan tablets' utility against COVID-19 in the community setting. The other study, also known as the PRESECO study, evaluates Avigan for treating adults with mild-to-moderate symptoms of COVID-19.
November 20, 2020 - The Ministry of Healthcare of the Russian Federation confirmed the 'permanent registration of Avifavir, which enables the drug to be used both in outpatient and inpatient settings. It is advisable to prescribe it from the first days of the disease.' In his report, the chief researcher of the university clinic of Ufa, professor, doctor of medical sciences Bakirov BA, emphasized that "Avifavir," based on the results of a comparative multicenter clinical study, demonstrated the effectiveness and good tolerance by patients. The conducted study met all the criteria of international requirements, so the results obtained can be submitted to the regulatory authorities as part of the drug dossier to obtain permission to use Avifavir in other world countries.
November 16, 2020 - Phase III study published in the International Journal of Infectious Diseases showed that early treatment with favipiravir might be associated with more rapid viral clearance of COVID-19.
November 6, 2020 - The Russian Direct Investment Fund and the ChemRar group of companies announced a permit for the outpatient use of the first Russian anti-coronavirus drug, Avifavir (Favipiravir), provided to COVID-19 patients free of charge. The drug is already provided free of charge under the compulsory medical insurance program to patients undergoing treatment for coronavirus in medical institutions.
October 30, 2020 - Appili Therapeutics Inc. announced that it had signed a collaboration, development, and supply agreement with Dr. Reddy's Laboratories Ltd. Global Response Aid. The agreements work together to coordinate and accelerate the worldwide development, commercialization, and distribution of Avigan® tablets (favipiravir) for the potential treatment and prevention of COVID-19.
October 30, 2020 - FDC Limited announced the launch of new strength variants of its Favipiravir brands– PiFLU and Favenza- to treat mild to moderate cases of COVID-19 in India. These prescription-only drugs will be available at all retail, medical outlets, and hospital pharmacies across the country from the 1st of November, 2020. The 800mg version of the drugs will help reduce the number of tablets taken by any patient by 75%. Patients must take 18 pills on the first day, followed by 8 tablets every day for the next 13 days.
October 29, 2020 - A review provides insights into the evidence-based evolving role of favipiravir in the management of COVID-19 infection with emphasis on the benefits of initiating an early antiviral therapy with a special focus on favipiravir, its pharmacodynamic, pharmacokinetic, in vitro, clinical data, and inclusion in the treatment protocols of COVID-19.
October 22, 2020 - Fujifilm Holdings Corp. announced it has partnered with Shanghai-based Carelink Pharmaceutical Co. to seek approval in China for Avigan to treat COVID-19 and influenza.
October 20, 2020 - Appili Therapeutics Inc. announced that investigators enrolled and dosed the first cluster of participants in Appili's CONTROL COVID-19 clinical trial.
October 16, 2020 - FUJIFILM Toyama Chemical Co., Ltd. announced that the Company filed an Application for Partial Changes to manufacturing and marketing approval matters of its anti-influenza drug Avigan® Tablet the Ministry of Health, Labour and Welfare in Japan. The filing seeks to add an indication and other items relating to novel coronavirus infections (COVID-19).
October 9, 2020 - Pre-clinical study: The potent antiviral efficacy of high favipiravir doses is in line with a recent study in which thrice-daily dosing of ∼1,400 mg⋅kg−1⋅d−1 of favipiravir resulted in significant reductions in virus infection in hamsters. Favipiravir plasma exposures were consistent in both studies, although the doses used were not completely the same.
October 3, 2020 - Moscow's Mayor Sobyanin said 'COVID-19 outpatients in Moscow will receive the antiviral drugs "Areplivir" and "Coronavir," which are versions of Avigan, for free.'
September 24, 2020 - The Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, and ChemRar Group have agreed to supply Avifavir, the world's first registered favipiravir-based drug against coronavirus and Russia's first drug approved for the treatment of COVID-19, to 17 countries. The drug has already been delivered to Belarus, Bolivia, Kazakhstan, Kyrgyzstan, Turkmenistan, and Uzbekistan.
September 23, 2020 - FUJIFILM Toyama Chemical Co., Ltd. announced that the primary endpoint had been met in phase III clinical trial of "Avigan Tablet" (generic name: favipiravir, "Avigan") conducted in Japan for patients with novel coronavirus infections. As an influenza antiviral drug approved for manufacture and sale in Japan, Avigan selectively inhibits RNA polymerase necessary for influenza virus replication.
September 18, 2020 - Russia-based R-Pharm announced the approval of Coronavir for outpatient treatment of mild to moderate COVID-19 coronavirus infection. Coronavir is manufactured at R-Pharm's facility in Yaroslavl, will be available in Russian pharmacies.
September 17, 2020 - Article: Rapid incorporation of Favipiravir by the fast and permissive viral RNA polymerase complex results in SARS-CoV-2 lethal mutagenesis.
September 11, 2020 - Appili Therapeutics Inc. announced that it had submitted a new protocol to its open investigational new drug application with the U.S. FDA to conduct a Phase 3 clinical study evaluating favipiravir, the early treatment outpatient setting for adult COVID-19 infections. Favipiravir is a broad-spectrum antiviral administered in oral tablet form.
September 3, 2020 - The start of clinical trials for the Japanese flu drug, Avigan, in the Philippines has been delayed anew because the ethics board of the Department of Health has not given its approval for the participation of three of four local hospitals in the trials, Health Undersecretary Maria Rosario Vergeire said. Japan turned over the Avigan (favipiravir) tablets to the Philippines, used by 100 patients with coronavirus disease (COVID-19).
September 2, 2020 - India review article 'Favipiravir: A new and emerging antiviral option in COVID-19. The main advantages of favipiravir are that it is administered orally and that it can be given to patients who are symptomatic but not ill enough to be hospitalized. '
August 19, 2020 - Dr. Reddy's Laboratories Ltd. announced the launch of AVIGAN® (Favipiravir) 200 mg Tablets in India. The launch is part of the global licensing agreement with FUJIFILM Toyama Chemical Co. Ltd. It grants Dr. Reddy's exclusive rights to manufacture, sell, and distribute AVIGAN (Favipiravir) 200 mg Tablets in India.
August 17, 2020 - The Philippines started 9-month clinical trials for Avigan to study the anti-flu drug's efficacy against the COVID-19 disease. Health Undersecretary Maria Rosario Vergeire said the clinical trials would include just four hospitals in Metro Manila.
August 14, 2020 - Fujifilm Holdings Corp. announced it expects to complete clinical tests in Japan of the antiviral drug Avigan, a potential candidate treatment for COVID-19, after a delay caused by difficulty in September securing enough patient data.
August 10, 2020 - Appili Therapeutics announced the U.S. FDA had granted the Company clearance to proceed after Appili filed an investigational new drug application for broad-spectrum antiviral favipiravir known as Avigan. Appili's Phase 2 clinical trial is leveraging the versatility of favipiravir as an oral tablet suitable for administration across a wide variety of care settings, including long-term care. Appili intends to enroll up to 760 participants in this Phase 2 clinical trial across the U.S. and Canada. In addition, health Canada provided regulatory clearance on May 21, 2020, for Appili's Phase 2 study evaluating FUJIFILM Toyama Chemical's (FFTC) favipiravir as a preventative measure against COVID-19 outbreaks.
August 4, 2020 - Sun Pharmaceutical Industries Ltd., the world's 4th largest generic pharmaceutical Company, announced on Twitter that it would launch favipiravir (Avigan) under the brand 'FluGuard' ₹35 per pill, making it the cheapest brand of the antiviral drug in India. Favipiravir is used to treat mild to moderate Covid-19 disease through an emergency use authorization from India's Drug Controller General. 'FluGuard' is the sixth generic of favipiravir to be launched in India, with Glenmark Pharmaceuticals Ltd being the first to launch it in June after conducting a 150-patient clinical trial.
August 4, 2020 - The Philippine government announced that it had begun clinical trials for Japanese anti-flu drug Avigan to see whether it would effectively treat COVID-19, the disease caused by the new coronavirus.
August 3, 2020 – Chromis, a joint venture established by the Russian Direct Investment Fund and ChemRar Group, announced the signing of a distribution agreement with South Africa's 3Sixty Biopharmaceuticals, a subsidiary of 3Sixty Global Solutions Group, to deliver Avifavir, the first Russian anti-COVID drug, to South Africa.
July 30, 2020 - The Philippine government said Thursday it would stockpile Japanese anti-flu drug Avigan to treat severe cases of the new coronavirus, as planned clinical trials for the drug draw closer.
July 28, 2020 - Fujifilm has not yet submitted the drug for approval to Japanese authorities as a treatment for COVID-19 and has said it will take that step as soon as possible. Health ministry official Yasuyuki Sahara said the government stands ready to review Avigan once Fujifilm submits it for approval. And Stanford University is soon to start a phase II trial of 120 patients with mild symptoms and could move to a phase III around September, said Stanford professor Yvonne Maldonado.
July 24, 2020 - Hyderabad: Optimus Pharma Pvt. Ltd Director P. Prashanth Reddy announced that their Company had received approval from the Drugs Controller General of India (DCGI) to manufacture the active pharmaceutical ingredient, Favipiravir, through its subsidiary, Optrix Laboratories, and manufacture and market its antiviral drug, Favipiravir tablets. The drug was jointly developed by Cipla and the Council of Scientific and Industrial Research's Indian Institute of Chemical Technology.
July 22, 2020 - Glenmark Pharmaceuticals Ltd. announced top-line results from a Phase 3 clinical trial in mild to moderate COVID-19 patients conducted across seven clinical sites in India.
July 18, 2020 - Fujifilm Holdings Corp. announced it would start a clinical study of the antiviral drug Avigan in Kuwait in collaboration with India's Dr. Reddy's Laboratories Ltd, up to 1,000 people to assess the flu drug's effectiveness as a COVID-19 preventive therapy.
July 17, 2020 - The Kingdom of Saudi Arabia is set to play a key role in developing a Russian COVID-19 vaccine that produced promising results in the first phase of human trials. Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said the Kingdom could be part of Phase III, involving thousands of people, expected to begin in August 2020.
July 13, 2020 - Glenmark Pharmaceuticals Ltd said it would lower its generic version of favipiravir, FabiFlu, to 75 rupees ($0.9983) per tablet for restricted emergency use for patients with mild-to-moderate COVID-19 symptoms in India. Due to better yield and scale, Glenmark benefits patients by reducing the price of oral antiviral FabiFlu® by 27 % in India.
July 1, 2020 - FUJIFILM Corporation announced a partnership with Dr. Reddy's Laboratories Ltd. and Global Response Aid concerning the development, manufacture, and sales of Avigan® Tablets (favipiravir), a potential drug for the treatment of COVID-19 disease. Because it has a mechanism of action that selectively inhibits viral RNA polymerase, thereby preventing viral proliferation, Avigan may have an antiviral effect on the novel SARS-CoV-2 coronavirus, classified into the same type of RNA virus as influenza viruses.
June 30, 2020 - Stanford Medicine researchers are launching a clinical trial to test whether an oral drug can reduce symptoms and viral shedding in people with COVID-19. The researchers aim to enroll 120 participants, beginning July 6, who was recently diagnosed with the disease but were not hospitalized.
June 15, 2020 - Istanbul Medipol University Faculty Member Assoc. Prof. Dr. Mustafa Guzel and his team managed to create the local synthesis of Favipiravir, used to treat COVID-19.
June 11, 2020 - Russian Direct Investment Fund and ChemRar Group have delivered the 1st batch of Avifavir drugs against the coronavirus to Russian hospitals. As many as 60,000 courses of Avifavir will be delivered to Russian hospitals in June. If necessary, production of Avifavir could be increased to 2m courses per year. Clinics and pharmaceutical organizations in Moscow, Leningrad, Novgorod, Kirov, and Nizhny Novgorod regions and the Republic of Tatarstan and Ekaterinburg have already received the first deliveries drug.
June 8, 2020 - Fujifilm Holdings said it would continue clinical tests of its anti-influenza drug Avigan, a potential treatment for people infected with SARS-CoV-2 coronavirus, beyond the initially scheduled end in June 2020 due to a lack of sufficient data.
June 2, 2020 - Dr. Monika Tandon, VP & Head, Clinical Development Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals, told Telangana Today, "Combining antiviral agents that have a good safety profile and act on different stages of viral life-cycle is an effective treatment approach to rapidly suppress initial high viral load and lead to an overall improvement in clinical parameters." Simultaneously Glenmark is also conducting phase 3 clinical trials of Favipiravir as a COVID-19 monotherapy option with 150 patients enrolled from 9 leading government and private hospitals across India.
June 1, 2020 - The Russian Direct Investment Fund, Russia's sovereign wealth fund, and the ChemRar Group announced that Avifavir, a Favipiravir-based drug, has received a temporary registration certificate from the Ministry of Health of the Russian Federation. Avifavir is Russia's first COVID-19 drug and has shown high efficacy in treating patients with coronavirus during clinical trials.
May 22, 2020 - Fujifilm Holdings Corp. said it is on course to supply the anti-influenza drug Avigan for 2 million COVID-19 patients by next March 2021, meeting a target set by the Japanese government to ramp up production of the potential treatment for the new coronavirus.
May 20, 2020 - Avigan, a candidate drug for treating COVID-19, has not shown apparent efficacy in treating respiratory disease in clinical trials so far, raising doubts about its approval by the end of this month as sought by the government sources familiar with the matter. "There is currently no data showing that Avigan has high efficacy," said Daisuke Tamura, an associate professor at Jichi Medical University specializing in pediatric infectious disease.
May 15, 2020 - Favipiravir Observational Study Group (principal investigator: Dr. Yohei Doi, Fujita Health University) released a preliminary report of the Favipiravir Observational Study in Japan on the Japanese Association for Infectious Diseases website. Given that over 80% of COVID-19 patients have a mild disease that often improves by supportive therapy, caution is required to interpret the efficacy of favipiravir based on the data presented here.
May 13, 2020: The ChemRar Group and Russia's sovereign wealth fund announced interim results of the multi-center, randomized, open comparative clinical trial of the drug Favipiravir (Avigan) tablets hospitalized with COVID-19 disease.
May 13, 2020: Japan's health ministry decided to allow pharmaceutical companies to bypass standard clinical trial procedures to facilitate the fast-track approval of the anti-flu medicine Avigan as an early-stage treatment for COVID-19 disease.
May 12, 2020: Glenmark Pharmaceuticals has initiated Phase 3 clinical trials in India on the antiviral tablet Favipiravir, for which it received approval from India's drug regulator DCGI in late April. Clinical trials have commenced, and over 10 leading government & private hospitals in India are enrolled for the study. Glenmark estimates study completion by July/August 2020.
May 4, 2020: Japanese Prime Minister Shinzo Abe said Monday he wants Avigan (favipiravir) approved for COVID-19 treatment in May, as Japan moves to fast-track approval remdesivir as well.
May 1, 2020: Japan will provide anti-flu drug Avigan free of charge to 43 countries for clinical studies on its efficacy as a coronavirus treatment, Foreign Minister Toshimitsu Motegi said to local media.
April 30, 2020: FUJIFILM Diosynth Biotechnologies teams with COVID-19 Therapeutics Accelerator to reserve manufacturing capacity and provide technical expertise to deliver future COVID-19 therapies.
April 30, 2020: Glenmark Pharmaceuticals announced that it had received approval from the Drug Controller General of India to conduct clinical trials on Favipiravir Antiviral tablets on COVID-19 disease patients. The product is a generic version of Avigan® of Fujifilm Toyama Chemical Co. Ltd., Japan, a Fujifilm Corporation subsidiary.
April 28, 2020: Japan will provide the anti-flu drug Avigan for free to 38 countries to treat patients with the new coronavirus.
April 15, 2020: Fujifilm accelerates the production of its influenza antiviral drug "Avigan® Tablet" for COVID-19.
April 9, 2020: Fujifilm announces phase II clinical study of its influenza antiviral drug "Avigan® Tablet" (favipiravir) for patients with COVID-19 collaboration Brigham and Women's Hospital, Massachusetts General Hospital, and UMass Medical School. Avigan was approved in 2014 as an anti-influenza drug in Japan. Avigan selectively inhibits RNA polymerase, necessary for influenza virus replication.
March 17, 2020: China's health leadership announced they found the Japanese-developed anti-influenza drug Avigan to treat COVID-19 disease patients effectively.
February 17, 2020: The Taizhou government of Zhejiang province China announced Avigan (favipiravir) was approved for marketing.
June 22, 2016: Fujifilm signs a patent license agreement on its anti-influenza drug Avigan Tablet* with China's major pharmaceutical Company Zhejiang Hisun Pharmaceutical.
November 11, 2015: Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults.
Avigan (Favipiravir) Clinical Trials
FujiFilm announces a new Phase III Clinical Trial of Anti-influenza Drug Avigan Tablet in Japan, Targeting COVID-19 Patients. Avigan (Favipiravir) continues to be tested in clinical trials.
ClinicalTrials.gov Identifier: NCT04600895 - The Phase 3 PRESECO (PREventing SEvere COVID-19 Disease) study is a double-blind, placebo-controlled, randomized, multi-center superiority trial investigating the safety and efficacy of Avigan/Reeqonus in the early treatment for adults infected with COVID-19 and showing mild-to-moderate symptoms. Investigators are enrolling participants at multiple clinical trial sites in the United States, Brazil, and Mexico. Participants are outpatients with mild-to-moderate symptoms who have had a recent positive COVID-19 test (within 72 hours of enrollment). Participants self-administer the drug regimen in their homes, with clinical investigators monitoring patients remotely. Last updated on August 13, 2021.