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STAT+: Eli Lilly’s Alzheimer’s drug gets thumbs down from European regulators
Eli Lilly's Kisunla was approved in the U.S. for Alzheimer's last year, but now advisers to the European Medicines Agency say it shouldn't be approved.
European Medicines Agency advisers said Friday that Eli Lilly’s Alzheimer’s disease treatment should not be approved, once again diverging from their U.S. counterparts.
The Committee for Medicinal Products for Human Use recommended against approving Eli Lilly’s Kisunla because it considered the risks of a type of brain swelling known as amyloid-related imaging abnormalities, or ARIA, to outweigh the treatment’s benefits.
Kisunla, also known as donanemab, was approved for use in the U.S. last year. In a 1,700-person Phase 3 trial, Kisunla slowed cognitive decline by up to 35% compared to placebo at 18 months. But there was a greater risk that patients taking the drug would experience ARIA. In the group taking Kisunla, there were three deaths seen to be related to treatment, compared with one death in the placebo cohort.
