STAT Plus: What does the latest twist in the Sarepta saga mean for the future of the FDA? We discuss

STAT Plus: What does the latest twist in the Sarepta saga mean for the future of the FDA? We discuss

Biotech What does the latest twist in the Sarepta saga mean for the future of the FDA? We discuss By Matthew Herper @matthewherper , Adam Feuerstein @adamfeuerstein , and Damian Garde @damiangarde January 24, 2020 Ruby Wallau for STAT E arlier this week, the Food and Drug Administration released documents that reveal a schism within the agency regarding its approval of Vyondys 53, a medicine to treat boys with Duchenne muscular dystrophy made by Sarepta Therapeutics ( SRPT ). The 2016 approval of the company’s first drug, Exondys 51, also for Duchenne muscular dystrophy, was controversial because it was approved on very early data. There was a voluble debate within the FDA over whether the treatment actually worked. Now, this saga seems to be repeating itself with a new drug. Unlock this article by subscribing to STAT Plus. To get you started, enjoy 50% off your first 3 months! GET STARTED Log In | Learn More What is it? STAT Plus 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 Online intelligence briefings Frequent opportunities to engage with veteran beat reporters and industry experts 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. GET STARTED



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