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Avigan trial to stretch beyond June as Japan’s coronavirus cases plunge

Avigan trial to stretch beyond June as Japan’s coronavirus cases plunge

TOKYO — Potential coronavirus treatment Avigan is now expected to take until July at the earliest to complete a clinical trial, further delaying government approval in Japan, Nikkei has learned.

A sharp decline in COVID-19 cases in Japan has made it difficult to secure enough patients for testing, according to people familiar with the matter.

The struggle to secure enough data is the latest setback to hopes that the Fujifilm Holdings-developed anti-flu drug can serve as a coronavirus remedy. Prime Minister Shinzo Abe’s government had initially expected to grant Avigan fast-track approval as a COVID-19 treatment in May, but with little evidence of its effectiveness, a decision was put off.

The clinical trial of Avigan began at the end of March with the goal of testing 96 patients to examine its efficacy and safety. The trial was supposed to conclude in June.

So far, however, the number of participants in the trial has stood at about 70% of the target, according to people familiar with the matter. The trial involves observing patients’ conditions for 28 days following the administration of the drug.

The trial has not gone smoothly. When it started in April, large participating hospitals were focused on treating seriously ill COVID-19 patients and could not receive people with more mild symptoms, the segment Avigan is intended for. By May, the overall number of patients started dwindling.

Fujifilm is now asking other hospitals to participate so it can complete the trial.

Japan’s health ministry has said it is prepared to approve the medicine as long as its efficacy is proven. But so far, evidence has been lacking.

June 6, 2020

https://asia.nikkei.com/

June 8, 2020 / Pharma News
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