Sarepta Therapeutics’ Elevidys Receives the US FDA’s Accelerated Approval for the Treatment of Duchenne Muscular Dystrophy
Shots:
- The US FDA has granted accelerated approval to Elevidys for the treatment of ambulatory pediatric patients aged 4 through 5yrs. with DMD with a confirmed mutation in the DMD gene
- The approval was based on the efficacy data from 2 clinical studies incl. (SRP-9001-102) & (SRP-9001-103) and safety data from (SRP-9001-101), (SRP-9001-102) and (SRP-9001-103). The results showed an increase in the expression of Elevidys micro-dystrophin to predict clinical benefit in individuals aged 4-5yrs. who do not have significant pre-existing Ab titers against the AAV rh74 vector
- Sarepta will continue to reinforce the Elevidys’ efficacy in an ongoing P-III study (EMBARK) which is set to complete in late 2023 with data expected in early 2024
Ref: Sarepta Therapeutics | Image: Sarepta Therapeutics
Related News:- Hansa Partner Sarepta Therapeutics Plans to Initiate a Clinical Study of Imlifidase for Duchenne Muscular Dystrophy
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
