Biogen and the Food and Drug Administration are at odds over the timing of a confirmatory trial for the company’s newly approved drug for Alzheimer’s disease, an issue of critical importance in determining whether the medicine is delivering benefits to patients.
Hours after the approval of Aduhelm on Monday, Biogen CEO Michel Vounatsos said that the company could take up to nine years to satisfy the FDA’s post-approval requirement that it conduct an entirely new clinical trial to confirm the benefit of the drug for patients with Alzheimer’s. Those remarks, made during an interview with CNBC, were not received well inside the agency because they suggested Biogen felt no urgency to complete the study in a timely manner, an FDA official said.
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