EU Drug Agency Recommends Approval of First Alzheimer’s Treatment Targeting Disease Progression

The EMA has reaffirmed its support for Lecanemab, a drug shown to slightly slow early-stage Alzheimer’s, but its use will be limited to a small subset of patients.

• The European Medicines Agency (EMA) has reiterated its recommendation to approve Lecanemab, a drug aimed at slowing early-stage Alzheimer’s disease progression, after a second safety review.
• Lecanemab, marketed as Leqembi in the U.S. since 2023, targets amyloid plaques in the brain and is designed for patients with mild cognitive impairment or early-stage Alzheimer’s.
• The EMA previously raised concerns about severe side effects, such as brain swelling and microbleeds, but concluded that the benefits outweigh the risks in a specific subset of patients.
• The drug is expected to benefit only a small fraction of Alzheimer’s patients—those in the early stages of the disease and without certain high-risk genetic markers.
• The European Commission has yet to make a final decision on the drug’s approval, leaving its availability in the EU uncertain at this time.

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