Neurologist and medical director of Ace Alzheimer Center Barcelona.
Less than four months after the European Medicines Agency recommended in July not to grant marketing authorisation for Leqembi™ (lecanemab) for the treatment of Alzheimer's disease, the EMA's Committee for Medicinal Products for Human Use (CHMP) has reassessed the available evidence to conclude that the benefits outweigh the risks.
The European Medicines Agency (EMA) has recommended not granting marketing authorization for Leqembi™ (lecanemab) for the treatment of Alzheimer's disease. The EMA's Committee for Medicinal Products for Human Use (CHMP) considers that its effect in delaying cognitive decline does not outweigh the risk of serious side effects associated with the drug, in particular swelling and possible bleeding in patients' brains. Leqembi™ was approved in 2023 in the United States.