European Commission approves first Alzheimer's treatment in EU
The European Commission has approved the first treatment for Alzheimer's disease in the EU that slows the progression of the disease rather than treating symptoms.
The treatment, based on the drug lecanemab and marketed under the brand name Leqembi, is recommended for patients in the early stages of Alzheimer's. It is only approved for people with one or no copies of the ApoE4 gene variant, as those with two copies have a higher risk of side effects such as brain swelling and bleeding.
The decision follows a "positive scientific assessment" by the European Medicines Agency (EMA), which concluded in November that Leqembi's benefits in slowing cognitive decline outweigh its risks for a specific group of patients. The approval comes with strict conditions of use and clear measures to mitigate potential harm, the Commission said.
Leqembi has already been approved in the US and the UK. A previous application was rejected by the EMA in July due to safety concerns.
© PHOTO HANS LUCAS COLLECTION
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