Amid significant controversy, the US Food and Drug Administration (FDA) last week approved the antiamyloid agent aducanumab (Aduhelm) for the treatment of Alzheimer’s disease, disregarding the recommendation by its own advisory panel not to approve the drug.

Advisory committee members had voted eight to one against approving the drug because they felt there was insufficient evidence of efficacy from clinical trials involving patients with early Alzheimer’s disease. Two other members said they were uncertain regarding efficacy. Multiple panel members have resigned in protest after the approval was announced.

As a condition of approval, the FDA is requiring Biogen to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. The agency can withdraw its approval if the drug fails to show clinical benefit in this trial.

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