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Biogen Says FDA Approves Updated Label For Alzheimer's Drug Aduhelm Injection - Quick Facts

Biotechnology company Biogen, Inc. (BIIB) and Japanese pharma firm Eisai Co. Ltd. (ESALY.PK, ESALF.PK) announced Thursday that the U.S. Food and Drug Administration (FDA) has approved an updated label for Aduhelm (aducanumab-avwa) injection 100 mg/mL solution. Aduhelm is indicated for the treatment of Alzheimer's disease.

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials. It clarifies the indication by emphasizing information about the disease stages studied in the Aduhelm clinical trials.

The approved update reads, "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 is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm.

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