Japan govt board: data on efficacy of COVID-19 drug candidate Avigan is inconclusive
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The Japanese Health Ministry said on Monday its medical review board concluded that clinical trial data to determine the efficacy of Fujifilm Holdings Corp’s COVID-19 drug candidate Avigan is inconclusive.
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The review board will re-examine Avigan’s effectiveness once additional data is submitted, the ministry said.
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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.
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A health ministry official did not elaborate reasons for the decision at a media briefing, but said one of the major topics at the review board meeting was the fact that clinical trial data submitted was acquired in so-called single-blinded tests.
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In a single-blinded clinical trial, doctors know whether patients are given an actual drug or a placebo, and the results of such trials tend to be less objective than those of double-blinded tests, in which neither doctors nor patients have such knowledge, the official said.
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Fujifilm finds it very regrettable that the board decided to continue its review, and it plans to work toward early approval, the company said in a statement.
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Japan has already approved Avigan, known generically as favipiravir, as an emergency flu medicine. But concerns remain as the drug has been shown to cause birth defects in animal studies.
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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.
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