Vaccine Info

Avigan Antiviral Medication

Avigan (Favipiravir) Antiviral Medication Description

Avigan (T-705) Tablet was approved for manufacture and sale in Japan in 2014 as an influenza antiviral medication. Avigan should be considered for use only when there is an outbreak of novel or re-emerging influenza virus infections in which other influenza antiviral medications are either not effective or insufficiently effective, and the Japanese government decides to use the drug as a countermeasure against such influenza viruses.

Avigan (favipiravir) was discovered by Toyama Chemical Co., Ltd., 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. 

Avigan is sold under various names, (favipiravir, FabiFlu, Avifavir, Ciplenza, FluGuard) undergoes an intracellular phosphoribosylation to be an active form, favipiravir-RTP (favipiravir ribofuranosyl-5′-triphosphate), which is recognized as a substrate by RdRp, and inhibits the RNA polymerase activity. Since the catalytic domain of RdRp is conserved among various types of RNA viruses, this mechanism of action underpins a broader spectrum of anti-viral activities of favipiravir.

Avigan is supplied only at the discretion of Japan’s Health, Labor, and Welfare Ministry. It is therefore only manufactured and distributed upon request by the Japanese Government. Avigan is not approved for distribution in the USA or any overseas countries.

Fujifilm signed a patent license agreement on its anti-influenza medication Avigan (favipiravir) Tablet with China's major pharmaceutical company Zhejiang Hisun Pharmaceutical during June 2016.

In the USA, Stanford University is conducting a phase II trial of 120 patients with mild coronavirus symptoms and could move to a phase III around September 2020, said Stanford professor Yvonne Maldonado on July 28, 2020. This study was last updated on July 27, 2020.

On June 1, 2020, Avifavir, a Favipiravir-based drug, 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 guidelines for the prevention, diagnosis, and treatment of new coronavirus infection COVID-19. Starting June 10, 2020, Avifavir was delivered to more than 50 Russian regions.

Glenmark Pharmaceuticals announced on July 13, 2020, 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.

And, 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 of virus in the Favipiravir treatment arm. Additionally, Glenmark’s Favipiravir was well tolerated with no serious adverse events or fatalities in the Favipiravir treated arm.

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Avigan (Favipiravir) Antiviral Medication Indication

Avigan (favipiravir) (FabiFlu) is effective against a wide range of types and subtypes of influenza viruses, including strains resistant to existing anti-influenza drugs.

Of note is that favipiravir shows anti-viral activities against other RNA viruses such as arenaviruses, bunyaviruses, and filoviruses, all of which are known to cause fatal hemorrhagic fever. These unique anti-viral profiles will make Avigan a potentially promising drug for specifically untreatable RNA viral infections.

On February 17, 2020, Zhang Xinmin, head of the China National Center for Biotechnology Department under the Ministry of Science and Technology, said at a news conference, that in human trials conducted in Shenzhen, Guangdong province, the anti-influenza Avigan (favipiravir) medication has shown promising results against the novel coronavirus and mild adverse reactions in patients.

Avigan (Favipiravir) Antiviral Dosage

The dosage of Avigan to treat COVID-19 disease patients is currently in various clinical studies.

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 10 days for oral administration of the drug.

However, reports indicate Avigan cannot be administered to expecting mothers or those who may become pregnant.

Avigan (Favipiravir) Antiviral News

  • August 4, 2020 - Sun Pharmaceutical Industries Ltd., the world's 4th largest generic pharmaceutical company, announced on Twitter that it will launch favipiravir (Avigan) under the brand ‘FluGuard’ at ₹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 the Drug Controller General of India. ‘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 has begun clinical trials for Japanese anti-flu drug Avigan to see whether it would be effective in treating COVID-19, the disease caused by the new coronavirus. The trials come as the Philippines is also conducting clinical trials for remdesivir, as well as interferon, an anti-viral agent.
  • July 30, 2020 - The Philippine government said Thursday it will 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 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 will start a clinical study of the antiviral drug Avigan in Kuwait in collaboration with India's Dr. Reddy's Laboratories Ltd. and will involve 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 the development of 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, which is expected to begin in August 2020.
  • July 13, 2020 - Glenmark Pharmaceuticals Ltd said it would lower the price of its generic version of favipiravir, FabiFlu, to 75 rupees ($0.9983) per tablet for restricted emergency use in patients with mild-to-moderate COVID-19 symptoms in India. Also, due to better yield and scale, Glenmark passes the benefits to 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) which is 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, as it is 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 have been recently diagnosed with the disease but not been hospitalized.
  • June 11, 2020 - Russian Direct Investment Fund and ChemRar Group have delivered the 1st batch of Avifavir drug against the coronavirus to Russian hospitals. As many as 60,000 courses of Avifavir will be delivered to Russian hospitals in June. Production of Avifavir could be increased to 2m courses per year if necessary. Clinics and pharmaceutical organizations in Moscow, Leningrad, Novgorod, Kirov, and Nizhny Novgorod regions, as well as in the Republic of Tatarstan and Ekaterinburg, have already received the first deliveries of the drug.
  • June 8, 2020 - Fujifilm Holdings said it will 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, 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 the 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 which often improves by supportive therapy, caution is required in interpreting 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), in tablets, on patients 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 being 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 for 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 has 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 subsidiary of Fujifilm Corporation.
  • April 28, 2020: Japan will begin providing the anti-flu drug Avigan for free to 38 countries for treating 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 the start of phase II clinical study of its influenza antiviral drug “Avigan® Tablet” (favipiravir) for patients with COVID-19, in collaboration with 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 have found the Japanese-developed anti-influenza drug Avigan to be effective in treating COVID-19 disease patients.
  • 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

ClinicalTrials.gov Identifier: NCT04346628: Oral Favipiravir Compared to Placebo in Subjects With Mild COVID-19 - last updated on July 27, 2020.

Clinical Trial NCT04349241: Efficacy and Safety of Favipiravir in Management of COVID-19 (FAV-001). This phase 3 clinical trial is to assess the safety and efficacy of favipiravir versus standard care therapy in the treatment of patients with COVID-19.

Clinical Trial NCT04358549: Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19. This is an open-label, randomized, controlled, multicenter Phase 2 proof-of-concept study of favipiravir in hospitalized subjects with COVID-19.

Clinical Trial NCT04346628Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild COVID-19. The objective of this Phase 2 study is to evaluate the efficacy of oral favipiravir compared with SOC in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.

Clinical Trial NCT04310228: Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019. The purpose of this study is to evaluate the efficacy and safety of favipiravir combined with tocilizumab in the treatment of COVID-19 disease.

Clinical Trial NCT04319900Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia. Estimated Study Completion Date: June 25, 2020

Clinical Trial NCT04303299: Various Combination of Protease Inhibitors, Oseltamivir, Favipiravir, and Hydroxychloroquine for Treatment of COVID19: A Randomized Control Trial (THDMS-COVID19.

Updated
08/05/2020 - 03:18