|
 Tokyo-based Eisai and its United States partner filed for Japanese
regulatory approval just over a year ago for the drug Adulhelm,
which was approved in the United States in June.
In a statement the panel cited inconsistent results from global
Phase III trials and a lack of clinical significance in the drug's
ability to reduce plaques in the brain. The panel said it would take
another look if further data is submitted.
Eisai and Biogen have jointly developed three experimental drugs for
the brain-wasting disease, which affects millions around the world
and has not seen a new treatment in decades.
Expectations among patient groups and investors for the drug have
been on a roller coaster for years. It was nearly abandoned after
disappointing trial results in 2019, but Biogen revived it after
reviewing data showing that higher doses of the drug could slow
disease progression.
[to top of second column] |
 The U.S. Food and Drug
Administration (FDA) approved the drug earlier
this year despite objections from an outside
advisory panel its clinical benefit was
unproven.
Biogen said on Monday it would cut the U.S.
price of Adulhelm, known scientifically as
aducanumab, in half amid complaints about its
high cost and slower than expected sales.
More than 8 million people in Japan are believed
to have dementia or cognitive impairment, while
treatment of Alzheimer's patients costs an
estimated 7.4 trillion yen ($65 billion) per
year.
($1 = 114.0900 yen)
(Reporting by Rocky Swift; Editing by Jason
Neely and David Holmes)
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