BIIB Biogen Inc

By Matt Grossman

Biogen Inc.'s recently approved Aduhelm drug for people with Alzheimer's disease will get updated labeling to emphasize the disease stages in which the drug's use was studied, Biogen said Thursday.

The Food and Drug Administration has approved the updated label, which would specify that the drug should be initiated in patients with mild cognitive impairment or mild dementia stage of disease. Those categories represent the populations in which treatment was studied in clinical trials.

"Based on our ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label update with the goal to further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval," Biogen's head of research and development, Dr. Alfred Sandrock Jr., said.

The new label specifies that "there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied."

Write to Matt Grossman at matt.grossman@wsj.com

(END) Dow Jones Newswires

July 08, 2021 08:02 ET (12:02 GMT)

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