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Pharmaceuticals

Japan approval for Avigan to treat COVID-19 will not come in May

Government hesitates amid concern it is rushing ahead before trial concludes

Fujifilm expects to raise output of Avigan up to 100,000 treatment courses by July 2020.   © Reuters

TOKYO (Kyodo) -- Japan has given up on approving Fujifilm Holdings Corp.'s anti-influenza drug Avigan this month for the treatment of patients infected with the new coronavirus, health minister Katsunobu Kato said Tuesday.

"We will continue the clinical study and clinical tests (of the drug) in June and onward. There is no change in our policy to approve the drug swiftly if its efficacy (against the coronavirus) is confirmed," Kato told a news conference.

There is a belief that Avigan, also known as favipiravir and developed by Fujifilm Holdings' unit Fujifilm Toyama Chemical Co., can be used as a treatment for the COVID-19, the respiratory illness caused by the coronavirus.

Prime Minister Shinzo Abe had expressed his hopes the drug could have received approval by the end of this month. But some experts raised concerns that the government was rushing to approve it before the final results of the clinical tests were known.

Kato said the government initially aimed to approve the drug if the interim results of clinical tests conducted by a team led by Fujita Health University showed an extremely high efficacy in treating coronavirus.

But a third-party panel that assessed the results of the interim report said that it was too early to judge it scientifically, according to Kato. The drug is feared to cause birth defects and cannot be administered to expectant mothers.

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