Posted by Michael Wonder on 16 Feb 2018
FDA opens new path for Alzheimer's treatments
16 February 2018 - Draft guidance comes after Merck failure, years of others.
U.S. drug regulators wants to let drug makers test Alzheimer’s disease treatments on patients years before the disease shows outward signs, and could approve the therapies based on subtle biological signals rather than proof they alleviate symptoms.
The FDA proposal will open new paths for drug makers after repeated failures from companies including Pfizer Inc., Eli Lilly & Co. and Merck & Co. It also poses a scientific challenge: Researchers don’t fully understand the biological progression of Alzheimer’s disease, leaving the industry without a clear finish line or target.
