FDA Advisory Committee Endorses Early Alzheimer's Treatment Drug Studied at Butler Hospital’s Memory and Aging Program
On June 10, 2024, the FDA Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted to endorse the drug “donanemab” for approval, recognizing its clinical benefit to treat early Alzheimer's disease. This endorsement brings hope for the millions affected by this devastating condition and marks a crucial step towards expanding the available treatment options.
“The advisory committee’s unanimous recommendation for FDA approval of donanemab represents a landmark moment in the treatment of Alzheimer’s disease. For the first time we have medications that target and remove a core pathology of AD that promote independence and quality of life for patients with AD,” said Dr. Stephen Salloway, Founder of the Memory and Aging Program (MAP). “By leveraging biomarkers, such as amyloid and tau imaging, researchers can identify patients most likely to benefit from targeted therapies like donanemab. This precision medicine approach, coupled with the growing understanding of the biology of aging, paves the way for the development of novel therapies that address the underlying causes of Alzheimer's disease.”
“As we await the FDA's final decision on donanemab's approval, the Memory and Aging Program remains committed to advancing research and clinical trials that bring us closer to more effective treatments and, ultimately, a cure for Alzheimer's,” said Edward Huey, MD, Professor of Psychiatry and Human Behavior at Alpert Medical School of Brown University and Director of MAP.
“We are proud to have played a role in the TRAILBLAZER-ALZ study and look forward to continuing our collaboration with leading institutions and pharmaceutical companies to improve the lives of those affected by this disease,” Huey said. “The potential approval of donanemab represents a significant step forward, but our work is far from over. We must continue fostering innovation, driving progress, and supporting the dedicated researchers, patients, families, and caregivers at the forefront of this fight. Together, we can move closer to a future where Alzheimer's is treated on an individual basis, its progression halted, and its onset prevented altogether.”
