TOKYO, October 14, 2022 – FUJIFILM Toyama Chemical Co., Ltd. (President: Mitsuhiro Sato) announced the decision to discontinue the development of its anti-influenza drug, Avigan® Tablet (Avigan; generic name: favipiravir), for use as a therapeutic drug against COVID-19.
In 2021, FUJIFILM Toyama Chemical began a phase III clinical trial in Japan with the target enrollment of 316 subjects, aimed at confirming Avigan’s efficacy to prevent the progression to severe symptoms in COVID-19 patients who have not yet been vaccinated. The enrollment was, however, terminated at 84 subjects in March 2022 following change of circumstances including improvement in the vaccination rate and the spread of the Omicron variants, which have lower symptom severity rates than conventional strains.
Subsequent analysis of clinical data from the 84 subjects has not shown significant results. Accordingly, the company has decided to discontinue further development on Avigan’s efficacy against COVID-19, and will withdraw its application to partially amend Avigan’s manufacturing and marketing approval in Japan for treating COVID-19.
Avigan® is an anti-influenza drug that had obtained manufacturing and marketing approval in Japan in March 2014 with an indication to treat new or reemerging influenza viruses. Administration of the drug to patients is considered if the government deems it necessary following the outbreak of a new or re-emerging influenza virus infection, to which other anti-influenza drugs prove ineffective or produce only insufficient effects.
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