Alzheimer Disease Treatment Donanemab Receives FDA Approval

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The US Food and Drug Administration (FDA) approved donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion (Kisunla), a treatment for adults with early symptomatic Alzheimer disease, including individuals with mild cognitive impairment or mild dementia with confirmed amyloid pathology.¹ Once-monthly Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, thus lowering treatment costs and number of required infusions.

“This approval marks another step forward in evolving the standard of care for people living with Alzheimer disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer 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," said Howard Fillit, MD, cofounder and chief science officer at the Alzheimer's Drug Discovery Foundation. “Diagnosing and treating Alzheimer disease sooner than we do today has the potential to meaningfully slow disease progression, giving patients invaluable time to maintain their independence for longer.”

Individuals with the least advanced Alzheimer disease experienced the strongest results with Kisunla in the phase 3 TRAILBLAZER-ALZ 2 study. Participants were analyzed over 18 months in 2 groups: (1) a group who was less advanced in their disease (participants with low to medium levels of tau protein) and (2) the overall population, which also included participants with high tau levels. Treatment with Kisunla significantly slowed decline in both groups, but those treated with Kisunla who were less advanced in their disease showed a significant slowing of decline of 35% compared with placebo on the integrated Alzheimer's Disease Rating Scale (iADRS). The response to treatment in the overall population was also statistically significant using the iADRS at 22%. Among the 2 groups, participants treated with Kisunla had up to a 39% lower risk of progressing to the next clinical stage of Alzheimer disease than those receiving placebo.

On average, Kisunla reduced amyloid plaques among the overall population of participants by 61% at 6 months, 80% at 12 months, and 84% at 18 months compared with the start of the study. One of the study goals was to remove amyloid plaques to minimal levels consistent with a visually negative scan using amyloid positron emission tomography. Then, if participants were confirmed to have reached these levels, they were able to complete treatment with Kisunla and switch to placebo for the remainder of the study.

"Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer 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," said Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly and Company. "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."

This approval follows a tumultuous journey for donanemab, but also a unanimous recommendation from FDA advisors.^2,3

References

1. Lilly's Kisunla™ (donanemab-azbt) approved by the FDA for the treatment of early symptomatic Alzheimer's disease. News release. July 2, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early

2. Kuntz L. Donanemab delay: FDA calls for last-minute meeting to discuss safety and efficacy. Psychiatric Times. March 8, 2024. https://www.psychiatrictimes.com/view/donanemab-delay-fda-calls-for-last-minute-meeting-to-discuss-safety-and-efficacy

3. Kuntz L. Donanemab: FDA advisors unanimously recommend for approval. Psychiatric Times June 10, 2024. https://www.psychiatrictimes.com/view/donanemab-fda-advisors-unanimously-recommend-for-approval