Vaccine Info

Avigan Antiviral Medication

Avigan 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 (favipiravir) 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.

Avigan Antiviral Medication Indication

Avigan (favipiravir) 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 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 Antiviral News

  • 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 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

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
05/24/2020 - 13:59