FDA Approves Eli Lilly’s Alzheimer’s Drug Donanemab, Offering New Treatment Option

1. FDA Approval: Eli Lilly's Alzheimer's drug donanemab, marketed as Kisunla, has received approval from the FDA, marking the third drug in the U.S. designed to slow the progression of the disease.
2. Mechanism: Donanemab functions as an anti-amyloid monoclonal antibody, targeting and eliminating amyloid plaques in the brain, a key feature of Alzheimer's disease.
3. Treatment: The drug is administered through monthly infusions, with the option to discontinue treatment once amyloid levels reach a specified threshold, potentially reducing treatment expenses and infusions.
4. Efficacy: Clinical trials showed that donanemab slowed cognitive and functional decline in patients with early symptomatic Alzheimer's disease by up to 22% compared to a placebo.
5. Cost: The list price for a 12-month treatment regimen is $32,000, although patients typically do not pay the full list price due to Medicare coverage.
6. Side Effects: Potential side effects include abnormalities in brain imaging, brain function complications, seizures, and hypersensitivity reactions to the infusion.
7. Market Impact: Donanemab joins Leqembi and the discontinued Aduhelm as the third FDA-approved amyloid-targeting drug, expanding treatment options for the nearly 7 million Americans affected by Alzheimer's disease.