Eli Lilly Receives FDA Approval for Donanemab to Treat Early Symptomatic Alzheimer's Disease

Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has approved Kisunla (donanemab-azbt) for the treatment of adults with early symptomatic Alzheimer's disease, including those with mild cognitive impairment or mild dementia stage of disease. Kisunla is an amyloid-targeting therapy that works by clearing amyloid plaques from the brain. In the pivotal TRAILBLAZER-ALZ 2 trial, Kisunla slowed clinical decline by 35% compared to placebo at 76 weeks in patients with low/medium tau levels. The approval represents a major advancement in Alzheimer's treatment and offers patients a new option to slow the progression of this devastating disease. Lilly will work to ensure broad patient access to Kisunla.