FDA, facing intense criticism, narrows use of controversial Alzheimer’s drug to patients with early-stage disease

The revised label clarifies that the drug, called Aduhelm, is intended for patients with early-stage disease — the population that participated in clinical trials of the drug, according to statements from the FDA and Biogen, the drug’s manufacturer. The drug was approved June 7 — the first Alzheimer’s medication cleared since 2003 — sparking heated debates about whether it slows cognitive decline, as it was intended to do.

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