EU Approves Eisai and Biogen's Lecanemab, Marketed as Leqembi, for Early-Stage Alzheimer's

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Updated Apr 15, 2025, 09:44 PM

The European Commission has approved the use of the antibody drug lecanemab, marketed as Leqembi, for the treatment of early-stage Alzheimer's disease. This approval marks the first time a therapy targeting the underlying processes of Alzheimer's has been authorized in the European Union. Lecanemab, developed by Eisai and Biogen, is intended for patients with mild cognitive impairment or mild dementia due to Alzheimer's. The drug works by removing amyloid deposits in the brain, which are believed to slow the progression of the disease. The approval follows a positive opinion from the European Medicines Agency (EMA). The authorization comes with strict conditions, including that it is only for patients who have one or no copies of the ApoE4 gene variant, as they are less likely to experience severe side effects such as brain swelling and bleeding. This limits the eligible patient population to a small fraction of those with Alzheimer's.

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Sources

dw.com(3)jp.reuters.com(2)sueddeutsche.de(2)efn.se(2)

Reuters Legal

@ReutersLegal

EU authorizes Eisai-Biogen's drug for early Alzheimer's treatment https://t.co/exww2NDxdR https://t.co/LOE6vfhYdM

DW Español

@dw_espanol

European Union authorizes the use of the drug #lecanemab against #Alzheimer in special cases Only people who have a certain form of the apolipoprotein E gene may be treated with this medication. /ju https://t.co/6yMi9Eyd8T

DW News

@dwnews

The European Commission has approved the use of the antibody lecanemab to treat early stage Alzheimer's. Lecanemab works by removing a rogue protein called amyloid, slowing the progress of the disease. https://t.co/zLH54qqgIx