The US Food and Drug Administration has narrowed the group of patients who could receive a controversial Alzheimer's disease drug, the Washington Post says.
The FDA approved aducanumab, Biogen's Aduhelm, in June, a decision that drew criticism and sparked resignations from an FDA advisory board. The board had voted in November against recommending approval and noted there was not enough data to gauge whether the drug was effective. While the FDA usually follows the recommendations of its advisory panels, the agency approved the drug under its accelerated approval pathway.
According to the Post, under the initial label, some 6 million people in the US with Alzheimer's disease may have been eligible for the treatment, which has a list price of $56,000 a year. NBC News previously reported that the drug could then cost the US government billions of dollars.
The new label now limits the drug to patients with early-stage disease, the Post says, noting that was the population in Biogen's trials. It estimates that the target patient population is now 1 million or 2 million.
According to CNN, Alfred Sandrock, the head of research and development at Biogen, says they submitted the new prescribing information in a bid to clarify the patient population studied in its trials.