FDA Approves Eli Lilly’s Alzheimer’s Treatment

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s amyloid-clearing Alzheimer’s drug, Kisunla (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion). Kisunla is the second disease-modifying anti-amyloid therapy to receive traditional FDA approval.  

On June 10, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that donanemab is effective for treating early symptomatic Alzheimer’s disease. The committee also found that the benefits of donanemab outweigh the associated risks of treatment. 

Kisunla works by reducing the number of amyloid beta plaques in the brain, one hallmark of Alzheimer’s disease. The buildup of these plaques, alongside other disease drivers, damages brain cells and contributes to symptoms like memory loss. The removal of plaques in early disease stages was shown to slow clinical and functional decline in Alzheimer’s by 35%—the first Phase 3 trial of its kind to achieve this.  

Those with mild cognitive impairment, a stage before Alzheimer’s disease, showed greater improvement at 60% slowing of disease progression. After one year of monthly infusions, nearly half (47%) of participants taking Kisunla showed no clinical Alzheimer’s progression compared to 29% in the control group. 

The FDA rejected Lilly’s application for accelerated approval of Kisunla in January 2023, citing an insufficient number of study participants who had received at least 12 months of treatment. Lilly shared the full study results of its Phase 3 trial, TRAILBLAZER-ALZ 2, in July 2023. 

“This approval represents sustained progress toward better treatments for the millions of people living with Alzheimer’s,” said BrightFocus President and CEO Stacy Pagos Haller. 

Individuals eligible to receive Kisunla are those with clinically diagnosed mild cognitive impairment or mild Alzheimer’s disease. A prior spinal tap or specialized brain scan must also confirm the presence of amyloid plaques in the brain. 

Kisunla was reported to have side effects in clinical trials, including cases of mild to moderate brain swelling and bleeding— a rare but well-known side effect in this drug class. Most cases did not produce symptoms and were resolved or stabilized according to study protocols.   

The total cost of Kisunla and individual out-of-pocket costs for treatment will vary depending on length of treatment and insurance coverage. Physicians may consider stopping Kisunla treatment if amyloid PET imaging indicates removal of amyloid plaques to minimal levels. Eligible individuals on Medicare may receive coverage and reimbursement for Kisunla treatment. Lilly has created a free support services line at  www.Kisunla.Lilly.com or call 1-800-LillyRx (1-800-545-5979). 

View the full press release for more details.  

View a list of Alzheimer’s treatments and learn more about the innovative research funded by BrightFocus Foundation’s Alzheimer’s Disease Research program.  

About BrightFocus Foundation     

BrightFocus Foundation is a premier global nonprofit funder of research to defeat Alzheimer’s, macular degeneration, and glaucoma. Through its flagship research programs — Alzheimer’s Disease Research, National Glaucoma Research, and Macular Degeneration Research — the Foundation has awarded nearly $300 million in groundbreaking research funding over the past 50 years and shares the latest research findings, expert information, and resources to empower the millions impacted by these devastating diseases. Learn more at brightfocus.org.