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Lilly drug to slow Alzheimer’s disease gains FDA approval

(Pixabay)
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, (Kih-SUHN-lah) 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.
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

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