New Eli Lilly Alzheimer’s treatment approved by U.S. FDA

INDIANAPOLIS — A new Alzheimer’s treatment for adults from Eli Lilly and Company has been approved by the U.S. Food and Drug Administration.

According to a news release from the company, Kisunla is a once-monthly intravenous injection for adults with early symptomatic Alzheimer’s disease, including:

• People with mild cognitive impairment
• People with the mild demential stage of AD, with confirmed amyloid pathology.

The release said that this treatment is the first, and only, therapy that targets amyloid plaque. Evidence supports stopping the therapy when the plaques are removed, which can result in fewer infusions and lower treatment costs.

Officials said amyloid is a protein produced in the body that can clump together to create plaques. Excessive plaque buildup can lead to memory and thinking issues related to Alzheimer’s disease. The treatment helps remove the buildup of amyloid plaques.

“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,” Anne White, the executive vice president and president of Lilly Neuroscience for Eli Lilly and Company, said in the release. “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.”

Officials said the treatment slowed cognitive and functional decline by up to 35%, compared to a placebo, at 18 months. Officials also said that once-monthly infusions reduced plaques on average of 84% compared to the start of the study. Nearly half of the participants in the student completed their Kisunla treatment in 12 months.

“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,” Howard Fillit, M.D., the co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation (ADDF), said in the release. “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.”

Officials said the total cost of the treatment will vary by patient on when they complete the treatment, as well as their insurance. For more information, visit Eli Lilly and Company’s website .

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