By FieldPulse Staff · March 19, 2026
Tags: launch, strategy
FDA confirms Sarepta can file supplemental NDAs for DMD drugs Vyondys and Amondys using 9-year ESSENCE data plus real-world evidence, averting potential withdrawal after confirmatory trial miss.
Sarepta Therapeutics announced on March 19, 2026 that the FDA confirmed the company can submit data from its 9-year ESSENCE confirmatory study — along with real-world evidence — in support of converting its Duchenne muscular dystrophy (DMD) exon-skipping drugs Vyondys (golodirsen) and Amondys (casimersen) from accelerated to full approval. The move was seen as a significant lifeline for both drugs. Sarepta had reported in November 2025 that Vyondys and Amondys failed to hit their confirmatory trial endpoints, raising the prospect of accelerated approval withdrawal. The FDA's indication that it