What was wrong with Aduhelm's label?
The FDA initially approved Aduhelm for all Alzheimer's disease, despite trials limited to mild-stage patients — a broad label that inflated market potential and Medicare exposure before being narrowed just one month later.
The FDA initially approved Aduhelm for Alzheimer's disease broadly, without limiting it to the early-stage patients who were actually studied. The congressional investigation found the FDA accepted a broad label indication despite a lack of clinical data on disease stages other than mild cognitive impairment and mild Alzheimer's, and that Biogen accepted the broad label despite internal reservations. On July 9, 2021, only a month later, the FDA narrowed the label to patients with mild cognitive impairment or mild dementia, and the same day called for a federal investigation into the approval. A broad label matters because it expands the potential market, which in turn influences pricing, Medicare budgeting and premiums.