Following weeks of fiery criticism for its wide-labeled approval for Biogen’s Aduhelm for anyone with Alzheimer’s disease, the FDA is now narrowin

Biogen, FDA walk back controversial Aduhelm label after weeks of fierce criticism

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2021-07-09 21:00:04

Following weeks of fiery criticism for its wide-labeled approval for Biogen’s Aduhelm for anyone with Alzheimer’s disease, the FDA is now narrowing the recommended window of patients to only those with milder forms of the memory-robbing disease.

Biogen on Thursday said the FDA approved an updated label for Aduhelm, also known as aducanumab, that recommends the amyloid-beta targeting antibody for people with mild cognitive impairment or mild dementia, aligned with those included in Biogen’s late-stage trials.

The FDA warns that there is “no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”

Biogen requested the update based on “ongoing conversations with prescribing physicians, FDA and patient advocates,” research head Alfred Sandrock Jr., M.D., Ph.D., said in a statement. The goal is to “further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval,” Sandrock added.

The slimmed approval, an unusually sudden result given Aduhelm was approved just a month ago, follows the FDA’s initial decision to award the treatment an “almost shockingly broad” label, as Bernstein analyst Ronny Gal put it. The original nod essentially gave Biogen free rein to the estimated 6 million Alzheimer’s patients living in the U.S.