The US Food and Drug Administration's rejection of Sarepta Therapeutics Inc.' Duchenne muscular dystrophy (DMD) treatment golodirsen came as a shock to many, raising questions about whether the fallout from the Exondys 51 (eteplirsen) review factored into the agency's decision.
Golodirsen Rebuff: Did Exondys 51 Review Strife Influence US FDA's Decision?
Sarepta cited two safety issues when announcing a complete response letter for its exon 53 skipping DMD drug golodirsen, but the US FDA's decision may be a result of the Exondys 51 approval from 2016, analysts suggest.
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