Japan Pauses Anti-Influenza Pill Clinical Study Targeting COVID-19

Tokyo-based FUJIFILM Toyama Chemical Co., Ltd. announced on March 11, 2022, a pending pause in enrollment in the currently ongoing phase III clinical trial in Japan concerning its anti-influenza drug Avigan® Tablet targeting patients infected with COVID-19.

Enrollment of this double-blind, placebo-controlled study began in April 2021, aimed at confirming Avigan's efficacy to prevent the progression to severe symptoms in COVID-19 patients.

The company's press statement stated '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 been 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.'

Therefore, FUJIFILM decided to terminate the enrollment of new subjects into this Avigan (favipiravir) 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, stated the company.

Avigan (favipiravir) is an anti-influenza drug that had obtained domestic manufacturing and marketing approval in March 2014 to treat new or re-emerging influenza viruses as the indication.

While influenza and SARS-CoV-2 are both viruses, they are different.

As of March 12, 2022, the U.S. FDA had not authorized Avigan for use against COVID-19.

During the early stages of the pandemic, this antiviral pill was authorized for treating COVID-19 in several countries, including Egypt, Japan, Serbia, Turkey, India, and Thailand.

Additional COVID-19 treatment news is posted at PrecisionVaccinations.com/antiviral.

Note: This news article edited the company's press release for clarity and repurposed it for mobile readership.