European regulators OK Alzheimer's treatment Leqembi after initial
doubts
[April 17, 2025]
By TOM MURPHY
European regulators have finally approved the Alzheimer’s treatment
Leqembi after an advisory committee initially rejected the drug last
summer and then reconsidered it.
The infused treatment from Japanese drugmaker Eisai and Biogen received
approval for patients in early stages of the fatal, mind-robbing
disease. The decision applies to all 27 members of the European Union
plus Norway, Iceland and Liechtenstein, the drugmakers said late
Tuesday.
The European Committee for Medicinal Products for Human Use initially
said last July that the drug should not receive marketing approval due
to concerns about its side effects. Those include brain bleeding and
swelling, which can be dangerous in rare cases.
Eisai asked the committee to reconsider its decision, and it then
recommended approval in November.
Leqembi clears a sticky brain plaque linked to the disease. A large
study has shown that it slowed memory and thinking decline by several
months in those who received the treatment compared to those who got a
dummy drug.
The drug was approved in Europe for patients with the brain plaque and
one or no copies of a certain gene, making them less likely to
experience side effects.
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The Biogen Inc., headquarters is pictured on March 11, 2020, in
Cambridge, Mass. (AP Photo/Steven Senne, File)
 The European approval confirms
Leqembi's positive risk-benefit profile, TD Cowen analyst Phil
Nadeau said in a research note. But he added that the drug's
European debut will likely be slow, developing over several years.
Eisai developed Leqembi and is co-marketing it with Cambridge,
Massachusetts-based Biogen Inc.
The drug and a competing treatment, Kisunla, from Eli Lilly and Co.
are the first to convincingly show a delay in cognitive decline for
patients. Both have both been approved by U.S. regulators.
But the European committee said last month that Kisunla shouldn’t
receive approval due to side effect concerns. Indianapolis-based
Lilly said it hopes to continue discussing the drug through a
decision reexamination.
Biogen shares rose about 25 cents to $117.23 in midday trading
Wednesday while broader indexes slipped.
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