Months after the Food and Drug Administration approved Biogen’s Alzheimer’s drug Aduhelm, Eli Lilly hopes to secure approval for its own similar landmark treatment. But the company’s data came under question by experts in a spirited back-and-forth with Mark Mintun, Lilly’s senior vice-president of neuroscience research and development, at the STAT Summit Thursday.
The pharma giant intends to submit its drug, called donanemab, to the FDA by the end of the year, based on a mid-stage study which achieved its primary goal of slowing the rate of cognitive decline compared to a placebo, Mintun said. Like Aduhelm, donanemab works by reducing amyloid plaques in the brain, a biomarker which the FDA established as a new but highly controversial standard for accelerated approval. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED 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. 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. This name will appear with your comment
https://www.statnews.com/2021/11/19/lilly-alzheimers-donanemab-aduhelm-efficacy/
