FDA releases fresh details on internal debate over controversial Alzheimer’s drug
June 22, 2021
Some experts have praised the FDA for approving Aduhelm. They say the drug’s data contains signals that it will, indeed, help slow brain deterioration in early-stage patients. James E. Galvin, an Alzheimer’s researcher at the University of Miami, said he believes accelerated approval was the right decision.
“It would have been nice if the second study had been positive,” Galvin said. “But I think there is a camp in neurology that thinks this makes sense and wants to see [effectiveness] demonstrated” in a confirmatory study.