WASHINGTON (AP) — The Food and Drug Administration (FDA) has approved new prescribing instructions that are likely to limit the use of a controversial new Alzheimer's drug.
The update comes one month after the approval of Aduhelm, which has sparked a wave of criticism over its price and questionable benefits.
The updated prescribing label says the drug is appropriate for patients with early or mild Alzheimer’s.
That’s a big change from the original FDA instructions, which said simply that the drug was approved for Alzheimer’s disease in general.
“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., M.D., Ph.D., Head of Research and Development at Biogen, the company behind the drug.
The change could ease some scrutiny from experts and lawmakers concerned about the cost of the drug.