In a significant milestone for Alzheimer’s treatment in Europe, the European Commission has granted approval to Leqembi (lecanemab), a groundbreaking therapy developed by Japanese pharmaceutical company Eisai and its U.S. partner Biogen. This decision marks the EU’s first authorization of a disease-modifying drug for Alzheimer’s disease, representing a major step forward in targeting the root cause of the condition.
Unlike conventional treatments that focus on managing symptoms, Leqembi works by reducing the accumulation of amyloid beta plaques in the brain, considered a hallmark of Alzheimer’s disease.
The therapy is indicated for patients in the early stages of the disease, specifically those carrying none or only one copy of the Apolipoprotein E4 (ApoE4) gene, a genetic variant linked to higher Alzheimer’s risk. Patients with two copies of the gene are excluded from treatment due to increased risks of adverse effects, including brain swelling and bleeding.
Leqembi has already received regulatory approval in major global markets, including the United States, United Kingdom, Japan and China, and is being rolled out under careful monitoring due to its complex safety profile.
The approval follows a comprehensive review of clinical trial data showing that Leqembi can modestly slow cognitive and functional decline when used in early Alzheimer’s cases.
Health experts across Europe are hopeful that this drug could mark the beginning of a new era in neurodegenerative care, while stressing the importance of early diagnosis and genetic screening for optimal patient selection.
Eisai and Biogen are now working closely with European healthcare providers to ensure proper access, education and monitoring systems are in place ahead of the drug’s market rollout.
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