The original approval of Biogen’s Alzheimer’s treatment was, for many, controversial enough. But on top of giving the amyloid-targeting antibody treatment a conditional OK, the FDA indicated the drug for all patients with Alzheimer’s — a population so broad that some analysts called it “shocking,” especially since the drug was only tested in late-stage trials for those with a mild and early form of the disease.
Now, with both Biogen and the FDA facing a litany of criticisms, the agency is backpedaling and has issued an updated approval saying that Aduhelm “should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia.”
“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 continuing to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option,” Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen, said in a statement.
Biogen, meanwhile, is under pressure to lower the cost of the treatment, which is slated to cost about $56,000 a year — a price tag that many say could have a devastating impact on Medicare.