"This is good news for patients with Alzheimer's disease. We've not had a disease modifying therapy approved ever," said Dr. Ronald Petersen, an Alzheimer's disease expert at the Mayo Clinic. Under that pathway, Biogen is required to conduct a confirmatory clinical trial, but has several years to do so, she said. "I'm surprised and disappointed," said Dr. Caleb Alexander, a drug researcher at Johns Hopkins who was on the FDA's advisory committee that voted against approval of Biogen's drug. It makes the drug available to patients while requiring the company to do more research to prove its benefit," said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation.

Source: Otago Daily Times June 07, 2021 21:56 UTC