The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of lecanemab as a treatment for early Alzheimer's disease. This decision marks a reversal from the committee's previous rejection of the drug a few months prior.
Lecanemab, marketed as Leqembi in the U.S., is co-developed by Eisai and Biogen. It functions by clearing amyloid plaques, a hallmark of Alzheimer's disease, from the brain. A pivotal clinical trial demonstrated that lecanemab slowed the decline in memory and thinking skills by several months in patients with early-stage Alzheimer's compared to those receiving a placebo.
While the observed cognitive benefits are considered modest, the CHMP's initial concerns centered on the potential side effects associated with lecanemab, including the risk of brain swelling (ARIA-E) and microhemorrhages (ARIA-H). These side effects, though rare, can be serious. Eisai requested a re-evaluation of the data, leading to the current positive recommendation.
The European Commission is now anticipated to make a final decision regarding marketing authorization within the next few months. Lecanemab has already received full approval from the U.S. Food and Drug Administration (FDA) and has been approved by regulators in other countries.
Eli Lilly's donanemab is a competing drug that has also been approved by the FDA.
