FDA Advisory Committee Members Raise Concerns About Aducanumab

In addition to concerns about the data supporting the FDA approval of aducanumab for patients with Alzheimer disease, FDA advisory committee members raised some unique concerns when they rejected the application in November 2020.

In addition to concerns about the data supporting the FDA approval of aducanumab for patients with Alzheimer disease, FDA advisory committee members raised some unique concerns when they rejected the application in November 2020. In an interview with Pharmacy Times, Pamela Spicer, senior analyst with Datamonitor at Informa Pharma Intelligence, explained their apprehension.

Notably, Spicer said the FDA worked more closely with Biogen on the approval than they typically would during other review processes. She said that because of this, some advisory committee members questioned the agency's objectivity.