European committee says Lilly Alzheimer's drug shouldn't get marketing
approval
[March 29, 2025]
A European regulatory committee rejected Eli Lilly’s
U.S.-approved Alzheimer’s disease treatment over potentially dangerous
risks of brain bleeding and swelling.
The European Medicines Agency committee said the benefits of the new
drug, Kisunla, did not outweigh the risks, and it recommended refusing
marketing authorization for it.
The agency’s Committee for Medicinal Products for Human Use said Lilly
can ask for a re-examination of its opinion.
Lilly said Friday that it hopes discussions about the drug continue with
the agency through re-examination. The Indianapolis drugmaker noted that
Kisunla has already been approved in Japan and China, among other
markets.
U.S. regulators approved Kisunla last July for mild or early cases of
dementia caused by the fatal, mind-robbing disease. That came a year
after they approved a similar drug, Leqembi, from Japanese drugmaker
Eisai.
The drugs are the first to show a delay in cognitive decline in
patients, but it amounts to a matter of months.
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This image provided by Eli Lilly shows the company's new Alzheimer's
drug Kisunla. (Eli Lilly and Company via AP)
 The European committee also said
last summer that Leqembi should not receive marketing authorization
due to some of the same concerns. But it reversed its decision a few
months later.
Both Kisunla and Leqembi are laboratory-made antibodies,
administered by IV, that target one contributor to Alzheimer’s —
sticky amyloid plaque buildup in the brain. Questions remain about
which patients should get the drugs and how long they might benefit.
Shares of Eli Lilly and Co. climbed more than $2 to $823.99 Friday
morning.
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