FDA Updates Biogen Alzheimer Drug Indications

The US Food and Drug Administration (FDA) approved an updated label for Aduhelm, Biogen Inc’s new Alzheimer drug, to emphasize the patient population studied in clinical trials.

Aduhelm, otherwise known as aducanumab, is an amyloid beta-directed antibody approved by the FDA in June. According to a Biogen press release, the FDA approved the following addition to the Indications and Usage section of Aduhelm’s label:

“Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”

Aducanumab’s approval sparked controversy due to concerns that findings from the clinical trials did not fully support the drug’s efficacy, as well as concerns that the FDA granted accelerated approval against the recommendation of an external advisory group.

“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,” said Alfred Sandrock Jr, MD, PhD, head of research and development at Biogen.

Reference:
FDA approves updated ADUHELM™ prescribing information to emphasize population studied in clinical trials. News release. Biogen Incorporated. July 8, 2021. Accessed July 8, 2021. https://newsroom.biogen.com/news-releases/news-release-details/fda-approves-updated-aduhelmtm-prescribing-information-emphasize