FDA decision on Eisai, Biogen
Alzheimer's drug due in January
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[July 06, 2022]
By Deena Beasley
(Reuters) -The U.S. Food and Drug
Administration will expedite its review of Eisai Co Ltd's and Biogen
Inc's experimental Alzheimer's drug lecanemab, with a decision due by
Jan 6, 2023, the companies said on Tuesday.
Lecanemab, like the partners' previous drug Aduhelm, is an antibody
designed to remove sticky deposits of a protein called amyloid beta from
the brains of people with early Alzheimer’s, a disease that leads to
memory loss and the inability to care for oneself.
The FDA controversially approved Aduhelm in June last year, although
only one of two late-stage trials showed it helped slow cognitive
decline. The FDA's own panel of outside experts had advised against
approval.
Biogen subsequently slashed its price for the drug to $28,000 per year
from an initial $56,000. But Medicare, the U.S. government health plan
for people over age 65, this year said it would only pay for Aduhelm if
patients were enrolled in a valid clinical trial, serving to sharply
curtail the medication's use.
Eisai in March downsized its role in Aduhelm, but remains the leader in
the 50-50 partnership's lecanemab program.
Shares of the Japanese company jumped on the news, gaining more than 4%
in Tokyo trade and making Eisai the second-biggest gainer on the
benchmark Nikkei 225.
Under the FDA's accelerated pathway, lecanemab needs to show it can
effectively interfere with underlying changes that lead to Alzheimer’s
dementia, rather than prove any impact on cognition. Such a "biomarker"
would be the level of amyloid proteins in the brain.
That is the same standard the FDA used for approving Aduhelm - leaving
many critics unconvinced of the drug's efficacy.
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Signage is seen outside of the Food and Drug Administration (FDA)
headquarters in White Oak, Maryland, U.S., August 29, 2020.
REUTERS/Andrew Kelly/File Photo
Eisai said it would have results
from a large, Phase 3 trial of lecanemab available this fall, which
will answer the question of whether the drug has an impact on
cognitive ability.
The 1,800-patient study is designed to show that
the drug can slow the rate of cognitive and functional decline by at
least 25%.
"Here in the U.S. we obviously will do our very best to make
lecanemab available within the allowable coverage by different
payers," Ivan Cheung, Eisai's U.S. chairman, told Reuters.
He said initial "top-line" results from the trial
are expected by late September.
Eisai said the FDA has agreed that results from that trial can serve
as a confirmatory study to verify the clinical benefit of lecanemab.
Depending on those results, Eisai said it could seek full FDA
approval of the drug before the end of its current fiscal year on
March 31, 2023.
The company said it initiated in March an application with Japan's
Pharmaceuticals and Medical Devices Agency, and aims to file for
approval of lecanemab during that same time period based on the
Phase 3 trial results.
Pending the trial findings, Eisai said it also plans to submit a new
drug application in Europe.
(Reporting By Deena Beasley; additional reporting by David Dolan in
Tokyo; Editing by Sam Holmes)
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