An experimental Alzheimer’s drug called donanemab received approval from a U.S. Food and Drug Administration advisory panel. The drug is intended to treat early symptoms of Alzheimer’s disease, such as mild cognitive impairment and mild Alzheimer’s dementia. While the FDA has yet to approve the drug, they typically follow the panel’s recommendations.
During the FDA’s Peripheral and Central Nervous System Advisory Committee hearing, which took place in Maryland, the advisers unanimously agreed that the benefits of donanemab outweigh any potential risks. Representatives from Eli Lilly, the pharmaceutical company behind donanemab, attended the meeting and presented clinical trial results demonstrating that the drug slowed cognitive and functional decline in individuals with early Alzheimer’s.
If approved, donanemab would become only the second medication available to slow the progression of Alzheimer’s symptoms. The first, Leqembi, was granted full FDA approval in July 2023. Donanemab functions by clearing amyloid buildup from the brain, although it has been associated with side effects such as brain swelling and minor bleeding.
The Alzheimer’s Association has expressed support for donanemab as a treatment for early Alzheimer’s disease, emphasizing the importance of having multiple approved treatments available. The organization’s president and CEO, Joanne Pike, highlighted the advancements being made in Alzheimer’s treatment and the need for more effective and safe treatment options.
Further steps towards donanemab’s approval include FDA review. Dr. Marc Siegel, a clinical professor of medicine at NYU Langone Medical Center, noted that donanemab is comparable to Leqembi in its mechanism of action and potential side effects. While donanemab may be slightly more effective than Leqembi, experts have raised concerns about focusing solely on amyloid formation in Alzheimer’s treatment.
Tau proteins, which play a role in the development of Alzheimer’s, are not the primary targets of drugs like donanemab and Leqembi. Additionally, other factors like neuroinflammation and neuronal transmission abnormalities are crucial targets for research in Alzheimer’s treatment.
Eli Lilly, the company behind donanemab, is exploring various approaches to treating Alzheimer’s and other forms of dementia, including targeting amyloid and tau proteins, as well as other types of dementia. The hope is to develop a range of effective treatments to address the complexities of Alzheimer’s disease.
In conclusion, the progress made with drugs like donanemab offers hope for individuals affected by Alzheimer’s disease, but there is still much to learn and explore in the field of dementia research. The FDA’s consideration of donanemab marks a significant step forward in the ongoing effort to combat Alzheimer’s disease and improve the quality of life for those impacted by this condition.