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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