Initially, the previous prescribing information for the drug — which was approved by the FDA last month — noted that aducanumab is indicated to treat Alzheimer’s disease but did not specify a certain stage of the disease.
“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. We are committed to continue to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option,” Dr. Alfred Sandrock, Jr., head of research and development at Biogen, said in the company’s announcement.
Under accelerated approval, aducanumab will still be studied as part of a Phase 4 confirmatory trial to verify its clinical benefit. If the trial does not verify the drug’s benefit, then the FDA could remove the drug from the market.