Professor of Neuroscience and Group Leader at the UK Dementia Research Institute, UCL.
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.
The drug lecanemab (Leqembi™) has received full approval as a treatment for early Alzheimer's disease by the US Food and Drug Administration (FDA), after confirming its clinical benefit in a trial involving 1,795 patients. The FDA highlights the warning that in rare cases it can cause serious and potentially life-threatening side effects.