In a decision hailed as a breakthrough for Alzheimer’s treatment, the Food and Drug Administration (FDA) approved Eli Lilly’s drug Kisunla for early-stage Alzheimer’s disease. Kisunla, known chemically as donanemab, is the third medication in a new class designed to slow the progression of this debilitating neurodegenerative disease.
The approval comes after years of research and development by Eli Lilly. The company’s initial attempt for an accelerated approval in early 2023 was denied by the FDA due to concerns about long-term safety data. However, a new 18-month clinical trial with over 1,700 participants provided convincing evidence.
“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease,” said Anne White, president of Eli Lilly’s neuroscience arm, in a press release. “We know these medicines have the greatest potential benefit when people are treated earlier in their disease.”
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The trial results showed that Kisunla slowed cognitive decline by 22% compared to a placebo over 18 months. The effect was even more pronounced in patients with milder disease progression, with a 35% decline in cognitive decline.
Kisunla is administered through a monthly injection and targets the buildup of amyloid plaque, a protein linked to Alzheimer’s disease. While not a cure, it offers significant hope for patients in the early stages of the disease by potentially preserving cognitive function for a longer period.
However, the drug is not without potential side effects. Brain swelling and bleeding were reported in some patients, a common concern with this class of Alzheimer’s medications. Lilly reports that the rates observed in the Kisunla trial were slightly higher compared to a competitor drug, Leqembi.
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Despite these considerations, the FDA’s approval marks a significant step forward in the fight against Alzheimer’s disease. Kisunla provides a new treatment option for patients and paves the way for further research in this critical field. Eli Lilly expects the drug to be available within the coming weeks.
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