FDA Panel Endorses Donanemab to Treat Early-Stage Alzheimer Disease

An FDA has voted to endorse donanemab (Eli Lilly and Company), a monoclonal antibody that is designed to slow the development of early symptomatic Alzheimer disease.¹ The Peripheral and Central Nervous System Drugs Advisory Committee voted 11-0 on the effectiveness of donanemab.² If donanemab is approved by the FDA in the future, it would mark the second disease-modifying drug to be granted full approval for Alzheimer.³

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“Today’s vote offers hope that donanemab will be approved in the coming months, but it’s important to look at this milestone in the larger treatment landscape for Alzheimer’s, which will entail a combination therapy and precision medicine approach,” said Howard Fillit, MD, Co-Founder and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation (ADDF), in a news release.³

Data from the Alzheimer’s Association show that 1 in 3 older individuals residing in the US die due to Alzheimer’s disease or a different form of dementia. The mortality rate of the disease is reported to kill more individuals than both prostate and breast cancer, according to study authors.¹

Although there is no cure to prevent the expansion of Alzheimer disease, donanemab could aid treatment options because its role is to enter the brain and bind to amyloid plaque, enabling the immune system to remove the plaque.¹

"We are confident in donanemab's potential to offer very meaningful benefits to people with early symptomatic Alzheimer's disease. It was unexpected to learn the FDA will convene an advisory committee at this stage in the review process, but we look forward to the opportunity to further present the TRAILBLAZER-ALZ 2 results and put donanemab's strong efficacy in the context of safety. We will work with the FDA and the stakeholders in the community to make that presentation and answer all questions," said Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience, in a news release.⁴

The TRAILBLAZER-ALZ 2 study is a phase 3, double-blind, placebo-controlled clinical trial that is intended to assess the safety and efficacy of donanemab among individuals aged 60 to 85 years old who have experienced early symptoms of Alzheimer disease, with the presence of Alzheimer disease neuropathology.⁴ The study included 1736 individuals who were randomly assigned to receive donanemab or a placebo. The results showed that at 76 weeks, individuals in the donanemab group had a rating score of -6.02 and the placebo group had a score of -9.27 based on a 0- to 144-scale score range.⁵

“It’s encouraging to see that some patients essentially enter remission, where they achieve full amyloid clearance with donanemab, with no resurgence in substantial plaque buildup for nearly four years,” said Fillit, in a news relase. “These findings are a direct result of biomarker tests that can detect, quantify, and monitor plaque buildup in the brain. Biomarkers will continue to revolutionize clinical trial design as we move towards developing drugs that target novel pathways guided by the biology of aging.”³

The findings from the study suggest that donanemab is able to significantly slow clinical progression of Alzheimer disease and amyloid and tau pathology at 76 weeks of treatment.⁵

“Donanemab has been very, very helpful to me,” said Myra Garcia, 65, an Alzheimer’s patient who lives in Upland, California, in a news release. “I have been on the clinical trial for about 2 to 3 years, and I can tell you that I have had not a single bit of problem with it.”²

References

1. FDA advisers endorse Eli Lilly’s early-stage Alzheimer’s drug donanemab. CNN Health. News release. June 10, 2024. Accessed June 11, 2024. https://www.cnn.com/2024/06/10/health/fda-committee-recommends-eli-lillys-alzheimers-drug-donanemab/index.html.

2. FDA advisors strongly back new Alzheimer’s drug, despite risks and limitations. NPR. News release. June 10, 2024. Accessed June 11, 2024. https://www.npr.org/sections/shots-health-news/2024/06/10/g-s1-3818/fda-advisors-back-alzheimer-drug-donanemab-despite-risks.

3. ADDF STATEMENT ON FDA ADVISORY COMMITTEE’S ENDORSEMENT OF DONANEMAB. Alzheimer’s Drug Discovery Foundation. News release. June 10, 2024. Accessed June 11, 2024. https://www.alzdiscovery.org/news-room/announcements/addf-statement-on-fda-advisory-committees-endorsement-of-donanemab.

4. U.S. Food and Drug Administration to Convene Advisory Committee Meeting to Discuss the TRAILBLAZER-ALZ 2 Study of Donanemab. Lilly Investors. News release. March 8, 2024. Accessed June 11, 2024. https://investor.lilly.com/news-releases/news-release-details/us-food-and-drug-administration-convene-advisory-committee.

5. Donanemab in Early Symptomatic Alzheimer Disease. JAMA Network. News release. July 17, 2023. Accessed June 11, 2024. https://jamanetwork.com/journals/jama/fullarticle/2807533.