On July 7, 2021, the Food and Drug Administration (FDA) posted a modified label for Aduhelm (aducanumab; Biogen Inc.) clarifying the population in which treatment should be initiated.

Aduhelm is an amyloid beta-directed antibody that was initially granted accelerated approval on June 7, 2021, for the treatment of Alzheimer disease (AD). Biogen submitted a supplemental biologics license application (sBLA) to the FDA, requesting addition of clarifying language to the FDA-approved indication for Aduhelm.

The revised label notes that “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.”

This indication was approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Food and Drug Administration (FDA). Full Prescribing Information for ADUHELM™ (aducanumab-avwa) injection, for intravenous use). July 7, 2021. Available at: click here. Accessed July 8, 2021.