European Medicines Agency Partially Approves Alzheimer's Drug Leqembi
New treatment gets conditional approval for specific patients in Europe
The European Medicines Agency (EMA) has conditionally approved Leqembi (lecanemab), a treatment for Alzheimer's disease, reversing an earlier decision.
Developed by Biogen and Eisai, Leqembi targets mild cognitive impairment or mild dementia due to Alzheimer's in adults.
The EMA initially rejected the drug in July due to concerns about side effects like potential brain bleeding.
However, it now recommends the drug for patients with a lower risk of these issues, specifically those with one or no copies of the ApoE4 gene, a known Alzheimer's risk factor.
Proper risk management strategies, such as controlled access programs and MRI monitoring, are required to minimize severe side effects.
EMA's decision will go to the European Commission for final approval, but individual countries will decide on pricing and reimbursement.
Leqembi is praised for tackling early-stage Alzheimer's, showing a reduction in cognitive decline by 25%.
The drug, along with Aduhelm, was authorized by the US FDA last year, and it received approval in the UK in August.