‘Embarrassing About-Face’: FDA’s Aduhelm Labeling Change Does Little To Improve Frustration Over Alzheimer’s Approval
US FDA’s update to Biogen’s Aduhelm label was the right move, drug policy experts say, but that doesn’t mean the agency should expect a round of applause. Instead, they expect it will only heighten the controversy and tension over the unexpected June accelerated approval of the pricey new Alzheimer’s disease drug and could further erode trust in the agency. The updated indication, which emphasizes initiating treatment in patients with mild disease, still gives plenty of wiggle room for wider prescribing.
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Acting US FDA Commissioner says it is standard for the Office of Neuroscience to issue broad labels like the one originally granted to Biogen’s new Alzheimer’s drug, but the agency declined to answer follow-up questions on such a policy. Woodcock continued to defend Aduhelm’s accelerated approval but conceded that the process might have been improved in an unusually tense public appearance.
US FDA Acting Commissioner’s request for an HHS OIG review related to the Alzherimer’s drug approval is fairly narrow and continues to frustrate critics who believe the drug should not be approved. Woodcock expressed confidence in the CDER team in the letter to OIG, framing the investigation request as a move to help ensure public trust in the FDA.
The US FDA revised labeling to clarify the target population, which could be helpful in reimbursement discussions for the Alzheimer's therapy.