Biogen, FDA at odds over timing of crucial confirmatory trial of Alzheimer’s drug

first_img Tags biotechnologydementiaSTAT+ What’s included? Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. By Adam Feuerstein and Matthew Herper June 8, 2021 Reprints 0Comments Biotech Matthew Herper Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED @matthewherper @adamfeuerstein GET STARTED What is it? Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. About the Authors Reprints 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.center_img Adam Feuerstein Log In | Learn More Senior Writer, Medicine, Editorial Director of Events Matthew covers medical innovation — both its promise and its perils. 0Comments STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. 0Comments Dominick Reuter/AFP/Getty Images [email protected] 0Comments [email protected] Biogen, FDA at odds over timing of crucial confirmatory trial of Alzheimer’s drug Create a display name to comment This name will appear with your comment There was an error saving your display name. Please check and try again.last_img read more