An experimental Alzheimer’s drug called donanemab received an endorsement from a U.S. Food and Drug Administration (FDA) advisory panel. The drug is intended to target symptoms of early Alzheimer’s disease, such as mild cognitive impairment and mild Alzheimer’s dementia. While the panel’s recommendation is not a guarantee of FDA approval, the agency typically follows the advice provided.
During the advisory committee meeting, experts unanimously agreed that the benefits of donanemab outweigh any potential risks. The drug’s manufacturer, Eli Lilly, presented clinical trial results showing that donanemab slowed cognitive and functional decline in individuals with mild cognitive impairment due to early stages of Alzheimer’s. If approved, donanemab would be only the second medication available to slow the progression of Alzheimer’s symptoms, following Leqembi, which received full FDA approval in July 2023.
Donanemab works by clearing amyloid buildup in the brain, but researchers have noted side effects such as brain swelling and tiny bleeds. Despite these concerns, the Alzheimer’s Association has welcomed the potential approval of donanemab, emphasizing the importance of having more treatment options for Alzheimer’s patients.
Dr. Marc Siegel, a clinical professor of medicine at NYU Langone Medical Center, highlighted the similarities between donanemab and Leqembi in terms of blocking amyloid formation. Donanemab has shown to be somewhat more effective than Leqembi in slowing the progression of Alzheimer’s, but it may also come with a higher risk of side effects and a higher cost due to its monthly dosage schedule.
However, some experts have raised concerns about the focus on amyloid formation in Alzheimer’s treatments, suggesting that other factors like tau proteins and neuroinflammation should also be considered. While donanemab shows promise in targeting amyloid, there is still ongoing research to address the complex nature of Alzheimer’s disease.
In response to these concerns, Eli Lilly stated that they are exploring multiple approaches to treat Alzheimer’s disease and other forms of dementia, including molecules targeting amyloid, tau, and other related factors. The development of new drugs like donanemab represents progress in the field of Alzheimer’s research, but there is still much work to be done to fully understand and effectively treat this devastating disease.