Japan

Fujifilm to terminate the enrollment of subjects in the phase III clinical trial of anti-influenza drug Avigan® Tablet in Japan, targeting COVID-19 patients

News Release

March 11, 2022

This news release is issued by FUJIFILM Corporation in Japan.
Fujifilm makes no representation that products on this news release are commercially available in all countries and regions(including US and EU).
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TOKYO, March 11, 2022—FUJIFILM Toyama Chemical Co., Ltd. (FUJIFILM Toyama Chemical; Head Office: Chuo-ku, Tokyo; President: Junji Okada) announces a pause in enrollment, as of the end of March, in the currently ongoing phase III clinical trial in Japan concerning its anti-influenza drug Avigan® Tablet (Avigan; generic name: favipiravir), targeting patients infected with novel coronavirus infections (COVID-19).

Enrollment of subjects in the ongoing phase III clinical trial in Japan began in April 2021, aimed at confirming Avigan’s efficacy to prevent the progression to severe symptoms in COVID-19 patients. With the recent spread of the Omicron variant that has lower symptom severity rates than conventional strains, and the assumption that a vast majority of patients who had recently being enrolled in the trial having infected by the Omicron strain, Fujifilm decided that, even if trials were continued under the current clinical trial protocol, it would be difficult to verify Avigan’s efficacy to suppress the symptoms from becoming severe, and that continuation of the placebo control trial would not lead to the subjects’ benefits. FUJIFILM Toyama Chemical has therefore decided to terminate the enrollment of new subjects into this trial. The clinical data of the patients enrolled in the trial will be analyzed, going forward, in compliance with the clinical trial protocol.

Thus far, serious adverse events whose causal relationship to the investigational drug cannot be denied have not been reported in this trial.

Overview of the ongoing phase III clinical trial in Japan

Start date

April 2021

Target subjects

Patients with early-onset COVID-19 having risk factors for progression to severe symptoms

Trial design

A double-blind, placebo-controlled clinical trial

Primary endpoint

Ratio of patients whose symptoms had become severe

About Avigan® Tablets

Avigan® is an anti-influenza drug that had obtained domestic manufacturing and marketing approval in March 2014 with the treatment of new or reemerging influenza viruses as the indication. Administration of the drug to patients is considered if a new or re-emerging influenza virus infection has occurred to which other anti-influenza virus drugs prove ineffective or produce only insufficient effects, and the government decides to use the drug as a measure to cope with this influenza virus.

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