July 8 (UPI) — Drugmaker Biogen revised the label for its new Alzheimer’s disease drug aducanumab, effectively recommending its use only in patients with mild cognitive impairment or dementia, the company confirmed Thursday.
The U.S. Food and Drug Administration approved aducanumab, branded as Aduhelm, last month, despite clinical trial data showing limited benefits of the drug in patients with Alzheimer’s.
The changes to the product label, which spells out proper use and safety information for the drug, include text specifying that treatment with aducanumab “should be initiated in patients with or mild dementia stage of disease, the population in which treatment was initiated in clinical trials,” Biogen said.
There is no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied in the clinical trials, the company acknowledged in a press release.
“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 head of R&D Dr. Alfred Sandrock said in the release.
“We are committed to continue to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option,” he said.
The FDA granted Aduhelm accelerated approval based on its ability to reduce levels of amyloid beta plaques in the brain, according to Biogen.
Amyloid beta plaques are amino acids that collect between neurons, or brain cells, and research has linked their presence with cognitive impairment, including dementia and Alzheimer’s disease, according to the Alzheimer’s Association.
However, FDA approval may be “contingent upon verification of clinical benefit in [future clinical] trials,” Biogen said.