FDA safety reports and clinical trial follow-up data

FDA Approves Eli Lilly's Alzheimer's Drug Kisunla™ for Early Symptomatic Disease on July 2, 2024

Jul 2, 2024, 06:00 PM

Eli Lilly's new Alzheimer's drug, Kisunla™ (donanemab-azbt), has received approval from the U.S. Food and Drug Administration (FDA) on July 2, 2024, for the treatment of early symptomatic Alzheimer's disease. This marks the second drug approved in the U.S. that can slow the progression of the disease, which affects nearly 7 million Americans. Clinical trials have shown that Kisunla™ can slow cognitive decline by up to 35% and reduce the risk of disease progression. However, it also carries significant safety risks. The drug is priced at $32,000 for a 12-month treatment, but patients can stop taking it once amyloid plaques are cleared from their brains. This approval expands the limited treatment options available for Alzheimer's patients in the U.S., with competitor Leqembi priced at $26,500 per year.