BIIB - FDA approves updated labeling for Biogen's Aduhelm

travellinglight/iStock via Getty Images Biogen (BIIB) and Eisai (ESALF) announce that the FDA has approved an updated label for Aduhelm (aducanumab-avwa) injection 100 mg/mL solution. The update includes an addition to the Indications and Usage section of the label to emphasize the disease stages studied in the clinical trials as below: Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. Aduhelm is indicated for the treatment of Alzheimer’s disease and is ok'd under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval may be contingent upon verification of clinical benefit in confirmatory trial(s).

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FDA approves updated labeling for Biogen's Aduhelm