Lilly Alzheimer’s Drug Donanemab Wins EMA Panel Backing

Eli Lilly’s Alzheimer’s therapy donanemab has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, a key step toward full European Union clearance. The antibody, marketed as Kisunla in the United States and several other countries, is recommended for adults with early symptomatic Alzheimer’s disease who have confirmed amyloid pathology and carry either no copies or a single copy of the ApoE4 gene. The CHMP endorsement is based chiefly on data from the Phase 3 TRAILBLAZER-ALZ 2 trial, which showed the monthly infusion significantly slowed cognitive and functional decline compared with placebo. A final marketing authorisation decision now rests with the European Commission, which typically rules within a few months.