Data on efficacy of COVID-19 drug candidate Avigan is inconclusive: Japan government board
22 December, 2020
The Japanese Health Ministry said on Monday (Dec 22) its medical review board figured clinical trial data to look for the efficacy of Fujifilm's COVID-19 drug candidate Avigan is inconclusive.
The review board will re-examine Avigan's effectiveness once additional data is submitted, the ministry said.
Fujifilm has been seeking approval for its antiviral drug Avigan as a treatment for COVID-19 in Japan since October after its late-stage study showed faster recovery time for patients with non-severe symptoms.
A health ministry official didn't elaborate reasons for the decision at a media briefing, but said among the major matters at the review board meeting was the actual fact that clinical trial data submitted was acquired in so-called single-blinded tests.
In a single-blinded clinical trial, doctors know whether patients are given an actual drug or a placebo, and the results of such trials have a tendency to be less objective than those of double-blinded tests, where neither doctors nor patients have such knowledge, the state said.
Fujifilm finds it very regrettable that the board made a decision to continue its review, and it plans to work toward early approval, the company said in a statement.
Japan has recently approved Avigan, known generically as favipiravir, as a crisis flu medicine. But concerns remain as the drug has been displayed to cause birth defects in animal studies.
Though Japan has seen far fewer coronavirus cases than many Western countries, new infections have been on the rise, hitting record highs in recent days.
Japan has reported a complete of 201,048 infections and 2,965 deaths from the respiratory disease because the outbreak began early this season, according to public broadcaster NHK.
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