FDA — authorised 12 December 2019
- Marketing authorisation holder: SAREPTA THERAPS INC
- Status: approved
🇺🇸 Vyondys 53 in United States
FDA authorised Vyondys 53 on 12 December 2019
Marketing authorisations
FDA — authorised 4 June 2024
- Application: NDA211970
- Marketing authorisation holder: SAREPTA THERAPS INC
- Indication: Labeling
- Status: approved
The FDA approved Vyondys 53, developed by Sarepta Therapeutics Inc, for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 2-5 years. This approval is based on the results of a clinical trial demonstrating the efficacy and safety of Vyondys 53 in this patient population. The approval was granted through the standard expedited pathway.
Vyondys 53 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is Vyondys 53 approved in United States?
Yes. FDA authorised it on 12 December 2019; FDA authorised it on 4 June 2024.
Who is the marketing authorisation holder for Vyondys 53 in United States?
SAREPTA THERAPS INC holds the US marketing authorisation.