U.S. drug regulators wants to let drugmakers 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 Food and Drug Administration proposal will open new paths for drugmakers 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.