The Food and Drug Administration on Thursday changed the prescribing label for Biogen’s Alzheimer’s treatment Aduhelm — narrowing its recommended use to patients with milder forms of the disease.
Biogen and the FDA described the Aduhelm label update as a clarification meant to better reflect data from clinical trials. But changing the label so soon will be seen as the FDA yielding to outside criticism that the drug’s approval — just one month ago — was overly permissive.
“FDA initiated meetings with the company to clarify labeling,” an FDA spokesperson told STAT. “The company agreed to and submitted revised labeling to clarify the population appropriate for initiation of treatment.”
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