Sarepta Therapeutics’ Elevidys Gains the US FDA’s Label Expansion Approval for Duchenne Muscular Dystrophy
Shots:
- Sarepta’s Elevidys has received the US FDA’s label expansion approval for DMD patients (≥4yrs.) having DMD gene mutations with traditional & accelerated approval for ambulatory & non-ambulatory patients, respectively. Full approval for non-ambulatory patients depends on confirmatory study
- The company is conducting a P-III (ENVISION) trial to validate the advantages of Elevidys in non-ambulatory DMD patients to fulfill the post-marketing requirement following accelerated approval
- Additionally, Elevidys is being developed in partnership with Roche signed in 2019 under which Sarepta is handling the approval process, commercialization & manufacturing activities across the US while Roche holds ex-US rights for the same
Ref: Sarepta Therapeutics | Image: Sarepta Therapeutics
Related News:- Roche Reports the Results of Elevidys in P-III Trial for the Treatment of Duchenne Muscular Dystrophy (DMD)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
