COVID-19:日本当局推迟批准Avigan:继续进行审议

COVID-19:日本当局推迟批准Avigan:继续进行审议

-当局需要其他数据才能做出决定-

厚生劳动省:

富士富山化学正在申请AVIGAN批准作为一种新的冠状病毒感染治疗药物。

厚生劳动省在12月21日举行的理事会会议上忘记了对“ AVIGAN”的审查决定。

它宣布已决定再次继续进行审议。

继续审议的理由:

根据厚生劳动省的说法

从此时获得的数据很难清楚地判断其有效性。

在再次进行审议之前,它将等待公司的其他数据(例如正在进行的临床试验)。

彭博社

https://www.bloomberg.co.jp/news/articles/2020-12-21/QLOT8SDWRGG001

Japan health ministry delays decision on Avigan for coronavirus

TOKYO

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 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 Asia

https://asia.nikkei.com/Spotlight/Coronavirus/Japan-health-ministry-delays-decision-on-Avigan-for-coronavirus

Ministry to continue deliberation on Avigan | NHK WORLD-JAPAN News

https://www3.nhk.or.jp/nhkworld/en/news/20201222_01/