image credit- shutterstock
Fujifilm Toyama Chemical Co. has announced 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 (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.
The company 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 analysed, going forward, in compliance with the clinical trial protocol.
