COVID-19: Japanese authorities postpone approval of Avigan: continued deliberation
-Additional data is required for the decision of the authorities-
Ministry of Health, Labor and Welfare:
FUJIFILM Toyama Chemical is applying for AVIGAN approval as a therapeutic agent for new coronavirus infections.
The Ministry of Health, Labor and Welfare has forgotten the decision at the council meeting held on December 21 over the examination of “AVIGAN”.
It announced that it had decided to continue the deliberation again.
Reason for continuing deliberation:
According to the Ministry of Health, Labor and Welfare
From the data obtained at this time, it is difficult to clearly judge the effectiveness.
It will wait for additional data from companies, such as clinical trials currently underway, before deliberation again.
Bloomberg
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