FDA accelerated approval of Aduhelm (2021)

FDA granted accelerated approval to Aduhelm on June 7, 2021

FDA staff and Biogen engaged in at least 115 meetings, calls, and substantive email exchanges over a 12-month period beginning in July 2019.

Later that month, Chairs Maloney and Pallone announced the Committees' investigation into FDA's decision to grant accelerated approval to Aduhelm.

Following the presentation, none of the committee members voted to recommend traditional approval for Aduhelm.

Following the drug's approval, several members of the FDA advisory committee publicly resigned in protest.

FDA and Biogen inappropriately collaborated on a joint briefing document for a key advisory committee.

FDA considered Aduhelm under the traditional approval pathway used for most drugs for nine months, before abruptly changing course and granting approval under the accelerated approval pathway after a three-week review period.

Aduhelm (aducanumab-avwa) For the treatment of alzheimer’s disease 6/7/2021 11/1/2024

A joint investigation released Thursday by House Democrats

“It is the agency’s job to frequently interact with companies in order to ensure that we have adequate information to inform our regulatory decision-making,” the agency said in a statement.

Biogen refuted the report’s implications, saying it “stands by the integrity of the actions we have taken.”

accelerated approval pathway — an option that was not presented to committee members.