EU Regulators Reject Eli Lilly's Alzheimer's Drug Over Safety Concerns

The European Medicines Agency cites risks of brain swelling and bleeding, prompting Eli Lilly to seek re-examination of the decision.

The European Medicines Agency's CHMP recommended against approving Kisunla, citing that safety risks outweighed its benefits.
Kisunla, approved in the U.S., UK, Japan, and China, slowed cognitive decline by up to 35% in clinical trials but showed significant risks of amyloid-related imaging abnormalities (ARIA).
ARIA occurred in 36.8% of Kisunla patients during trials, with 1.6% experiencing serious events, including three fatalities.
Eli Lilly plans to request a re-examination of the decision, referencing the EMA's prior reversal on a similar drug, Leqembi, after further review.
Company officials remain confident in Kisunla's safety and efficacy, emphasizing the urgent need for more Alzheimer's treatment options in Europe.