Japan's Shionogi says COVID treatment did not meet endpoint in
late-stage trial
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[May 13, 2024]
TOKYO (Reuters) - Japan's Shionogi & Co said on Monday its
pill-based treatment for COVID-19 did not meet the primary endpoint of
showing a statistically significant reduction of 15 common symptoms of
the illness in a global, late-stage trial.
The company's pivotal Phase 3 study (SCORPIO-HR) of ensitrelvir did
however demonstrate a potent antiviral effect compared to placebo, the
company said.
WHY IT'S IMPORTANT
Shionogi said previously it expected the pill, known commercially as
Xocova, to deliver $2 billion in annual sales if it secured U.S.
approval.
Xocova would compete with Pfizer's antiviral drug Paxlovid.
Shionogi's CEO told the Nikkei newspaper in March that the company
expected to be able to sell the drug in the U.S. in early 2025.
CONTEXT
Xocova was granted emergency approval by Japanese regulators in November
2022, making it the nation's first domestically produced oral treatment
for COVID. It received full approval in Japan in March 2024.
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The logo of Shionogi & Co Ltd is displayed at their Tokyo branch
office in Tokyo, Japan February 24, 2023. REUTERS/Androniki
Christodoulou/File Photo
The Japanese government bought 2
million courses of the drug, most of which remain unused and are set
to be destroyed, according to a Kyodo report this month.
The drug was granted Fast Track designation by the U.S. Food and
Drug Administration in 2023.
The SCORPIO-HR trial is a part of the U.S. National Institutes of
Health's (NIH) public-private partnership for COVID treatments and
vaccines.
WHAT'S NEXT
The company said it will continue working with regulatory bodies to
explore routes to making ensitrelvir available, without giving
further details.
(Editing by Jan Harvey)
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