Ignoring the Experts: Implications of the FDA's Aduhelm Approval.

Abstract

In early June 2021, the U.S. Food and Drug Administration ("FDA") granted Accelerated Approval to Aducanumab ("Aduhelm") for treating Alzheimer's disease. The decision was immediately engulfed in controversy because the agency ignored the Scientific Drugs Advisory Committee's unanimous recommendation not to approve the drug. The FDA granted the approval based on Aduhelm's ability to lower beta-amyloid levels. However, the agency had not previously indicated this as a surrogate clinical end for the trial, and its own scientific analysis failed to show that amyloid changes correlate with cognitive or functional changes for Alzheimer's patients. This decision sets dangerous precedent and has the potential to transform the approval process for new drugs including, but not limited to, those meant to treat Alzheimer's.