Japan review of Avigan says efficacy for COVID-19 treatment inconclusive -Kyodo
17/12/2020 01:40
TOKYO, Dec 17 (Reuters) - Japanese health authorities say it
is difficult to determine the efficacy of Fujifilm Holdings
Corp's 4901.T antiviral drug Avigan as a treatment for
COVID-19, Kyodo News reported on Thursday.
Fujifilm has been seeking approval for the drug in Japan
since October after its late-stage study showed faster recovery
time for patients with non-severe symptoms. urn:newsml:reuters.com:*:nL4N2H70PL
In its latest assessment, the Pharmaceuticals and Medical
Devices Agency raised several concerns, including the fact that
doctors were aware which patients had received the drug or a
placebo, Kyodo said, citing government sources. The assessment
also acknowledged, however, that approving it for COVID-19 would
be "meaningful" as treatment options were limited, Kyodo said.
The agency's assessment will serve as key material for the
health ministry's review panel, which is expected to decide on
Dec. 21 whether to approve the drug for COVID-19 treatment in
Japan, Kyodo added.
Fujifilm's shares fell 3.8% in early trade, while the
broader Tokyo market .TOPX was flat.
While nowhere near the severity seen in the United States
and parts of Europe, novel coronavirus infections and related
deaths have spiked to record highs in Japan in recent days.
Infection cases total about 187,000 and deaths reached 2,755 as
of Wednesday, according to public broadcaster NHK.
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.
(Reporting by Chang-Ran Kim; Editing by Stephen Coates)
((ran.kim@thomsonreuters.com; +81-3-4520-1228;))