FDA cites patient, caregiver risk tolerance as factors in Alzheimer’s approval

FDA’s decision to grant accelerated approval to aducanumab was influenced by conversations with Alzheimer’s patients and caregivers who said they were willing to accept uncertainty about its benefit, according to FDA officials responsible for the decision.

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research (CDER), Billy Dunn director of CDER’s Office of Neuroscience, and Peter Stein, director of CDER’s Office of New Drugs, explained the approval of Aduhelm aducanumab from Biogen Inc. (NASDAQ:BIIB) in a commentary published Wednesday in The Washington Post. ...