The Food and Drug Administration approved Biogen’s Aduhelm to treat Alzheimer’s disease, the first new treatment approved for the disease since 2003. The drug was approved using the accelerated approval pathway, which is typically used when a medication for a serious or life-threatening illness is found to have a significant therapeutic advantage over existing treatments.
Aduhelm represents a first-of-its-kind treatment approved for Alzheimer’s disease in that it is the first therapy that targets the disease’s fundamental pathophysiology. As part of the accelerated approval provisions, which enable Alzheimer’s patients’ early access to treatment, FDA requires Biogen to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify the drug’s clinical benefit, the FDA may withdraw its approval.
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