Japan health ministry delays decision on Avigan for coronavirus

Nikkei -- Dec 22
The Japanese health ministry's expert board on Monday postponed a decision on whether to approve Fujifilm Holdings' Avigan for coronavirus treatment, opting to examine more evidence to determine its efficacy.

"This is not a rejection of Avigan's effectiveness," a ministry representative said. The board will continue with its deliberations once additional clinical trial results come out, with a decision now expected no earlier than January.

Fujifilm called the ministry's decision extremely regrettable.

The company has sought approval for Avigan, originally developed for the flu by unit Fujifilm Toyama Chemical, as a coronavirus treatment since October. The drug led to faster recovery times among patients with "non-severe" pneumonia as a complication of COVID-19, according to clinical trial results from the company.

But the ministry's board is believed to have taken issue with the fact that Fujifilm ran a single-blind trial, in which doctors knew which patients received the drug as opposed to a placebo. Single-blind trials are considered less reliable than double-blind trials, where neither patients nor doctors know who receives the drug.

- Nikkei

新型コロナウイルスの治療薬と期待されている「アビガン」について、厚生労働省の審議会は「有効性の判断が困難」として現段階での承認を見送り、審議を継続することを決めました。  アビガンは富士フィルム富山化学が開発したインフルエンザの治療薬で、10月には厚労省に新型コロナウイルスの治療薬としての製造・販売の承認を申請していました。20日に開かれた厚労省の審議会では、実施された治験の方法などについて議論が交わされ、「現時点で得られたデータから有効性を明確に判断することは困難」として、承認見送りを決めました。今後、アメリカなどで実施中の臨床試験の結果などを待って来年以降に再度、審議するということです。 - ANNnewsCH