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May 1, 2020

Fujifilm Accelerates production of its Influenza Antiviral Drug "Avigan® Tablet" for COVID-19.

FUJIFILM, Medicine

FUJIFILM, Medicine

TOKYO, April 30, 2020 — FUJIFILM Corporation has announced the expansion of its manufacturing capacity at FUJIFILM Toyama Chemical Company. That would significantly increase the production of its influenza antiviral drug “Avigan® Tablet” (generic name: favipiravir) for treating patients with COVID-19.

To further boost the supply of Avigan, Fujifilm is allocating additional capacity at its FUJIFILM Wako Pure Chemical Co., Ltd. facility in Japan, for production of pharmaceutical intermediates used to manufacture Avigan. Besides, Fujifilm has established strategic partnerships with domestic and overseas companies for various manufacturing processes to source raw materials and pharmaceutical substances.

Fujifilm expects to progressively increase the monthly production of Avigan up to 100,000 treatment courses by July 2020, approximately 2.5 times more compared to the beginning of March when the company first began its current production run. Also, Fujifilm plans to further accelerate production up to 300,000 treatment courses by September 2020.

According to Fujifilm, the Japanese government plans to stockpile two million treatment courses of Avigan, as part of the Japanese government’s emergency economic package announced on April 7. Fujifilm said it continues to respond to requests from the Japanese government and will also engage with other countries after consultation with the Japanese government.

Avigan, approved in Japan for manufacture and sale as an influenza antiviral drug, selectively inhibits viral RNA polymerase necessary for influenza virus replication. Avigan may have an antiviral effect on the SARS-CoV-2 coronavirus. Because, like influenza viruses, coronaviruses are single-stranded RNA viruses that also depend on viral RNA polymerase. To determine Avigan’s safety and efficacy to treat COVID-19, Avigan, as an investigational product, is being administered in clinical studies to COVID-19 patients.

A treatment course is the amount of Avigan Tablet described by the Japanese Association for Infectious Diseases in its guidance for a regimen of favipiravir to treat COVID-19. This 14-day treatment regimen includes two loading doses of 1800 mg each on Day 1, followed by two maintenance doses of 800 mg each on Days 2 through 14.

Avigan Tablet was approved for manufacture and sale in Japan in 2014 as an influenza antiviral drug. The drug is considered for use only when there is an outbreak of novel or re-emerging influenza virus infections in which other influenza antiviral medications are insufficiently productive.

Meanwhile, FUJIFILM Corporation has announced the initiation of a U.S. phase II clinical trial to evaluate the safety and efficacy of this influenza antiviral drug for patients with COVID-19, a respiratory infection caused by the novel SARS-CoV-2 coronavirus.

On March 31, Fujifilm announced the start of phase III clinical trial of Avigan for COVID-19 patients in Japan.

The clinical trial in the U.S. will enroll approximately 50 patients with COVID-19 in collaboration with Brigham and Women’s Hospital, Massachusetts General Hospital, and the University of Massachusetts Medical School.

Fujifilm said it would continue to work to establish a treatment method for COVID-19 patients through conducting clinical trials and to contribute to ending the spread of this global pandemic as soon as possible by increasing the production of Avigan in collaboration with strategic partners worldwide.

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Edited & Posted by the Editor | 11:39 AM | Link to this Post

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