European regulators have reversed their earlier stance on the Alzheimer’s drug lecanemab, recommending its marketing authorisation after initially deeming its risks to outweigh its benefits. The European Medicines Agency (EMA) made the announcement after a re-evaluation of the drug’s efficacy in treating Alzheimer’s disease, a neurodegenerative condition that affects an estimated 7.8 million people in the European Union.
Lecanemab, marketed under the brand name Leqembi, is administered as an intravenous drip every two weeks. It works by targeting amyloid beta, a protein that forms sticky plaques in the brains of Alzheimer’s patients, and has shown promise in slowing cognitive decline in clinical trials.
However, when the EMA first reviewed Leqembi in July, they expressed concerns about the potential for serious side effects, including brain swelling and bleeding. At the time, regulators determined that the drug’s benefits did not outweigh these risks. The drug was also restricted to patients with one or no copies of the ApoE4 gene, a known risk factor for Alzheimer’s, as individuals with two copies of the gene were considered at higher risk for adverse effects.
The revised recommendation comes with strict guidelines. Leqembi will only be available through a controlled access program to ensure it is prescribed to the appropriate patient population, and patients will be closely monitored for side effects through regular brain scans.
This decision aligns with previous approvals in other regions. In 2023, US regulators gave the green light to Leqembi, and in August, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) also approved it. However, despite its approval, the drug is not yet available on the UK’s National Health Service (NHS) due to concerns that the benefits do not justify its high cost.
The EMA’s revised stance represents a cautious but hopeful step forward in the treatment of Alzheimer’s disease, which remains an incurable condition with limited treatment options. While Leqembi’s approval may provide relief for some patients, it will be subject to ongoing scrutiny as regulators balance the drug’s potential benefits with its associated risks.
