EMA Rejects Eli Lilly's Alzheimer's Drug Kisunla Over Safety Concerns

The European Medicines Agency cited risks of brain swelling and bleeding, but Eli Lilly plans to seek a re-examination of the decision.

The European Medicines Agency (EMA) has denied marketing authorization for Eli Lilly's Alzheimer's drug Kisunla, citing safety risks including amyloid-related imaging abnormalities (ARIA).
Kisunla, which slows cognitive decline by up to 35% over 18 months, has already been approved in the US, UK, Japan, and China.
The EMA's Committee for Medicinal Products for Human Use highlighted potentially fatal risks of brain swelling and bleeding as key factors in its decision.
Eli Lilly has announced plans to request a re-examination of the EMA's decision, emphasizing confidence in the drug's safety and efficacy.
Kisunla is part of a new class of Alzheimer's treatments targeting amyloid plaques, similar to Eisai's Leqembi, which faced initial rejection by the EMA but later gained restricted approval.