( MENAFN - PR Newswire) While the endorsement of a second anti-amyloid is emblematic of a new era, a combination therapy and precision medicine approach will be needed to guide the next generation of treatments. NEW YORK, June 10, 2024 /PRNewswire/ -- Today, the FDA Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that donanemab shows clinical benefit for the treatment of early Alzheimer's disease. If approved, donanemab would become the second disease-modifying drug for Alzheimer's to receive full approval, expanding the arsenal of available drugs needed to treat Alzheimer's with combination therapy.
"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," says Dr. Howard Fillit, Co-Founder and Chief Science Officer of the Alzheimer's Drug Discovery Foundation (ADDF). "If approved, donanemab will expand the first class of disease-modifying drugs, serving as the building blocks for future generations of drugs.
Anti-amyloids are not a silver bullet, but they offer opportunities for patients to modify the course of the disease while the field works towards developing more novel therapies that target the underlying biology." The donanemab trials demonstrate the field's ability to conduct innovative and rigorous biomarker-powered trials that provide a definit.