In June, the FDA approved aducanumab (Aduhelm) to treat patients with Alzheimer’s disease using the agency’s accelerated approval pathway, despite significant concerns about the evidence regarding the drug’s safety and effectiveness. The agency’s approval decision contradicted the recommendations of its own advisory committee, which voted overwhelmingly against the evidence presented in support of the drug. Soon after approval, three members of the committee resigned in protest. …
Post Author: Michael K. Gusmano, PhD and Karen J. Maschke, PhD
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