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.
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