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Lilly drug to slow Alzheimer’s disease gains FDA approval

Last Updated 2 weeks by Amnon J. Jobi | Amnon Front Page

INDIANAPOLIS (WISH) — Lilly’s drug that can slow Alzheimer’s disease has received the approval of the U.S. Food and Drug Administration, the Indianapolis-based pharmaceutical giant announced Tuesday.

FDA advisers voted unanimously in June that donanemab’s ability to slow the disease outweighs its risks, including side effects like brain swelling and bleeding that will have to be monitored.

The drug, known commercially as Kisunla, became the second Alzheimer’s drug cleared in the U.S. that’s been shown to convincingly slow cognitive decline and memory problems due to Alzheimer’s.

The FDA approved a similar infused drug, Leqembi, from Japanese drugmaker Eisai last year.

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A news release from Lilly says Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in a study, and reduced participants’ risk of progressing to the next clinical stage of disease by up to 39%

Kisunla is a therapy that targets amyloid plaque found in the brain, a known feature of people with Alzheimer’s disease.

The therapy involves once-monthly infusions of 30 minutes, which were found to reduce amyloid plaques on average by 84% compared to the start of the study, Lilly says.

Previous reporting from The Associated Press contributed to this report.


“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options. We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis. Our deepest thanks to the patients and their loved ones for participating in our clinical programs and to Lilly scientists and collaborators persevering over decades of research. Each year, more and more people are at risk for this disease, and we are determined to make life better for them.”

Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly & Co.

“This approval marks another step forward in evolving the standard of care for people living with Alzheimer’s disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer’s community. As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients. Diagnosing and treating Alzheimer’s sooner than we do today has the potential to meaningfully slow disease progression, giving patients invaluable time to maintain their independence for longer.”

Dr. Howard Fillit, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation