Amid significant controversy, the US Food and Drug Administration (FDA) has approved the anti-amyloid agent aducanumab (Aduhelm, Biogen/Eisai) for the treatment of Alzheimer's disease (AD), disregarding the recommendation by its own advisory panel not to approve the drug.
Aducanumab was approved using the accelerated approval pathway, which can be used to fast-track a drug that provides a meaningful therapeutic advantage over existing treatments for a serious or life-threatening illness.
However, under this pathway, the FDA requires Biogen to conduct a new randomized, controlled clinical trial to verify the drug's clinical benefit. In an FDA release, the agency said if the drug fails to show clinical benefit in this trial it has the option to withdraw its approval.
Aducanumab's approval marks the first new treatment approved for AD since 2003 and is the first to target beta-amyloid, the hallmark pathology of the disease.
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