Eli Lilly Alzheimer's drug approved by US FDA
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[July 03, 2024]
By Julie Steenhuysen and Mariam Sunny
(Reuters) -The U.S. Food and Drug Administration on Tuesday approved Eli
Lilly's treatment for early Alzheimer's, making it the second therapy
for slowing progression of the brain-wasting disease that will be
available to U.S. patients.
The approval for donanemab, to be sold under the brand name Kisunla,
followed the recommendations of the agency's outside experts, who
unanimously backed its use in patients with early Alzheimer's disease,
saying the benefits of the drug outweighed its risks.
“This is real progress," said Joanne Pike of the Alzheimer’s
Association. “Having multiple treatment options is the kind of
advancement we’ve all been waiting for — all of us who have been
touched, even blindsided, by this difficult and devastating disease.”
Like Eisai and Biogen's rival drug Leqembi, which was approved a year
ago, donanemab is designed to clear an Alzheimer's-related protein
called beta amyloid from the brain.
A key differentiating factor for donanemab is the drug's finite dosing,
which allows patients to stop taking the treatment once brain scans no
longer show amyloid plaques.
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Lilly priced its drug at $695.65 per vial, or about $32,000 for
12-months of treatment consisting of 13 infusions. That's slightly
higher than Eisai's Leqembi, which costs $26,500 a year.
BMO analyst Evan Seigerman said the price reflects the fact that
patients can stop treatment versus chronic treatment with Leqembi.
"The details of how it will play out in clinical practice are still
unclear, but I think it will save a lot of money and patients will like
that a lot better," said Dr. Erik Musiek, a Washington University
neurologist at Barnes-Jewish Hospital.
"I think that, coupled with the monthly dosing, will make this an
attractive option," he added.
In Lilly's large, late-stage trial, donanemab slowed the progression of
memory and thinking problems by 29% compared with a placebo. It also
caused brain swelling in nearly a quarter of patients and brain bleeding
in nearly a third, but most cases were mild.
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Lilly Biotechnology Center is shown in San Diego, California, U.S.
March 1, 2023. REUTERS/Mike Blake/File Photo
![](http://archives.lincolndailynews.com/2024/Jul/03/images/ads/current/bees_lda_HEROES_2024.png) As it did for Leqembi, the FDA
placed its strongest "boxed" safety warning on donanemab's
prescribing label, flagging the risk of potentially dangerous brain
swelling and bleeding.
One key difference is that donanemab will require five MRI scans to
check for side effects, while Leqembi requires four, which could be
an advantage for the Eisai drug in centers where such scans are
scarce, RBC Capital analyst Brian Abrahams said in a research note.
Eisai and Biogen have started submitting data to the FDA to support
approval of a monthly maintenance dose to be given as an IV
infusion, as well as a weekly injected version of Leqembi that
patients could receive at home.
Lilly's drug is expected to be used mostly by patients enrolled in
the U.S. government's Medicare health plan for people age 65 and
older. Medicare last year began covering Alzheimer's drugs that
receive standard FDA approval.
Morningstar analyst Damien Conover said he expects Lilly's drug to
generate peak annual sales of over $5 billion, and "a fairly evenly
split market between donanemab and Biogen’s Leqembi."
More than 6 million Americans have Alzheimer's disease, according to
the Alzheimer's Association.
(Reporting by Julie Steenhuysen in Chiccago, Deena Beasley in Los
Angeles and Bhanvi Satija and Mariam Sunny in Bengaluru; Editing by
Bill Berkrot)
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