US FDA panel backs approval for Eisai-Biogen Alzheimer's drug Leqembi
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[June 10, 2023]
By Leroy Leo and Julie Steenhuysen
(Reuters) -A panel of expert advisers on Friday unanimously agreed that
a late-stage trial of Eisai and Biogen's Alzheimer's drug Leqembi
verified the benefit of the treatment for those at an early stage of the
disease, clearing the way for traditional U.S. approval.
All six advisers on the panel voted in favor of Leqembi for treatment of
the mind-wasting illness.
Regular approval by Food and Drug Administration - a decision expected
by July 6 - is likely to expand Medicare payment for the treatment.
That approval would also make Leqembi the first disease-modifying drug
ever to achieve the regulatory milestone. Current treatments only treat
symptoms but do not change the course of the disease, which affects 6
million Americans, according to the Alzheimer's Association.
Leqembi won accelerated approval by the FDA in January based on its
ability to remove sticky amyloid plaques from the brain. The panel on
Friday considered Eisai's large confirmatory trial designed to show the
drug benefited patients.
That study, published in November, showed the drug slowed cognitive
decline by 27% in early Alzheimer's patients, but was also associated
with some serious side effects for some patients, including brain
swelling and bleeding or microhemorrhages.
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"I believe the benefit versus risk are beneficial, acceptable and in
line with this class of therapeutics, especially considering the burden
of the disease and the progressive nature of the disease," said panel
member Dr. Tanya Simuni, professor of neurology at Northwestern
University Feinberg School of Medicine.
"Overall, it demonstrated clearly that this is an effective treatment in
the population as it was defined," said Dr. Robert Alexander, committee
chair and an Alzheimer's expert at the Banner Alzheimer's Institute. He
added that he thought the study "clearly demonstrated a clinical
benefit," calling the results "robust."
SIDE EFFECTS
FDA also asked the panel to weigh in on Leqembi's side effects in
certain patient populations.
Those included patients taking drugs that prevent blood clots, those who
have a gene variant called APOE4 that increases the risk of Alzheimer's,
and those with a rare condition called cerebral amyloid angiopathy (CAA),
in which the protein amyloid that the drug targets builds up in the
walls of arteries in the brain and can cause bleeding.
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![](../images/061023PIX/health35.jpg)
The Alzheimer's drug LEQEMBI is seen in
this undated handout image obtained by Reuters on January 20, 2023.
Eisai/Handout via REUTERS/File Photo
![](http://archives.lincolndailynews.com/2023/Jun/10/images/ads/current/businessdirectory_dailycover_2023.png) Members of the panel generally said
the risks for those with two copies of the APOE4 gene were balanced
by the drug's benefits, although they urged the FDA to strengthen
language in the drug's prescribing label recommending genetic
testing for the risk gene.
Some on the panel raised concerns about giving Leqembi to patients
taking anticoagulants. Others said patients should be given the
option as long as they are made aware of the risks.
The panel also said it would not recommend excluding patients with
CAA, which can be hard to diagnose, from taking the drug. It
suggested limiting Leqembi's use in patients with the most severe
cases of the condition, called cerebral amyloid angiopathy-related
inflammation, because of the heightened risk of brain bleeding.
Under accelerated approval, Medicare restricted payment of the drug
to those in a clinical trial, but no such trials are underway for
Leqembi, resulting in negligible sales. Most U.S. Alzheimer's
patients are Medicare-eligible.
The federal agency that runs Medicare has said it will pay for the
treatment if doctors participate in a health agency database, known
as a registry, but has yet to release details of its plan.
Wall Street analysts widely expect the FDA to grant traditional
approval for the drug. Analysts have forecast Leqembi sales topping
$1 billion in 2026 and reaching $5.7 billion by 2030.
Alzheimer's Association CEO Joanne Pike in a statement urged
approval and expanded patient access "without barriers."
“We are in full agreement with the FDA Advisory Committee that
Leqembi provides clinical benefit and that this benefit outweighs
the risks." she said.
(Reporting by Leroy Leo and Khushi Mandowara in Bengaluru and Julie
Steenhuysen in Chicago; Editing by Bill Berkrot)
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