FDA updates label for Alzheimer's drug Aduhelm Rxing

Shares of both Biogen (Nasdaq: BIIB) and Eisai (TYO: 4523) were up following the news that the US Food and Drug Administration had amended the labelling for their Aduhelm (aducanumab-avwa), which, somewhat controversially, in June became the first treatment in two decades to gain approval in the treatment of Alzheimer’s disease.

The update, which was made at Biogen's request, includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials for Aduhelm injection 100mg/mL solution, as follows:

Aduhelm is indicated for the treatment of Alzheimer’s disease. 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.