Three specialists resign as FDA advisors over approval of Alzheimer’s drug

Enlarge / The Meals and Drug Administration headquarters in White Oak, Maryland. (credit score: Getty | Congressional Quarterly)

Fallout continues from the Meals and Drug Administration’s contentious determination this week to approve Biogen’s Alzheimer’s drug Aduhelm (aducanumab) regardless of an absence of efficacy knowledge.

Three specialists who sat on an advisory committee for the FDA have now resigned over the choice.

The advisory committee reviewed the information behind Aduhelm final November and voted overwhelmingly in opposition to approval. Of the 11 advisors on the committee, 10 voted “no” on the query of whether or not Biogen had collected sufficient proof to point that the drug is efficient. The remaining advisor voted “unsure.”