Sarepta Announces FDA Acceptance of sNDAs for AMONDYS 45® and VYONDYS 53®
Sarepta announced that the FDA accepted supplemental NDAs for AMONDYS 45 and VYONDYS 53 for filing, assigning a PDUFA target action date of February 28, 2027. The applications seek to convert accelerated approvals to traditional approvals, supported by the Phase 3 ESSENCE study and real-world evidence, despite the confirmatory trial missing its primary endpoint.
Key figures
- Drug Name
- AMONDYS 45 (casimersen) and VYONDYS 53 (golodirsen)
- Phase Of Trial
- Phase 3
- Pdurga Date
- February 28, 2027
- Patients treated
- > 1,800
- Ambulation delay years
- 3 and 4
- Ventilation delay years
- 7.5
AI analysis
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