FDA approves Eli Lilly’s Kisunla for Alzheimer’s treatment

The U.S. Food and Drug Administration (FDA) has approved Kisunla (donanemab-azbt), an Alzheimer’s treatment developed by Eli Lilly and Company (NYSE: LLY). This treatment, specifically designed for adults with early symptomatic Alzheimer’s disease, includes those with mild cognitive impairment (MCI) and the mild dementia stage of Alzheimer’s, with confirmed amyloid pathology.

Priced at $350 million for a monthly 20 mL IV infusion, Kisunla is heralded as the first and only amyloid plaque-targeting therapy with evidence supporting the cessation of therapy upon the removal of amyloid plaques. This innovative approach could significantly reduce treatment costs and minimize the frequency of infusions needed for patients.

Anne White, executive vice president and president of Lilly Neuroscience, expressed her enthusiasm about the approval: “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,” she said, thanking the patients, their loved ones, and Lilly scientists for their dedication.

Kisunla works by aiding the body in removing excessive amyloid plaque buildup in the brain, a key factor in Alzheimer’s disease progression. Clinical trials, specifically the TRAILBLAZER-ALZ 2 Phase 3 study, have shown that Kisunla significantly slows clinical decline, particularly in patients less advanced in the disease, with up to a 39% lower risk of progressing to more severe stages.

Additionally, Kisunla has been shown to reduce amyloid plaques by up to 84% at 18 months, compared to baseline, with the possibility of discontinuing treatment once minimal levels are achieved, as confirmed by amyloid positron emission tomography (PET) scans.

Despite its benefits, Kisunla may cause amyloid-related imaging abnormalities (ARIA) or serious infusion-related reactions. Howard Fillit, M.D., Co-Founder and Chief Science Officer at the Alzheimer’s Drug Discovery Foundation (ADDF), highlighted the drug’s potential: “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.”