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

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland.Getty | Congressional Quarterly

Fallout continues from the Food and Drug Administration’s contentious decision this week to approve Biogen’s Alzheimer’s drug Aduhelm (aducanumab) despite a lack of efficacy data.

Three experts who sat on an advisory committee for the FDA have now resigned over the decision.

The advisory committee reviewed the data behind Aduhelm last November and voted overwhelmingly against approval. Of the 11 advisors on the committee, 10 voted “no” on the question of whether Biogen had collected enough evidence to indicate that the drug is effective. The remaining advisor voted “uncertain.”

→ Continue reading at Ars Technica

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