(Reuters) -The U.S. Food and Drug Administration allowed the expanded use of Sarepta Therapeutics’ gene therapy for patients with Duchenne muscular dystrophy aged four and older on Thursday, sending shares of the company up 36% in extended trading.
The agency gave traditional approval to patients four years and above who can walk, as well as accelerated approval for those who cannot.
The FDA gave accelerated approval to the therapy – the first of its kind for DMD in patients aged between four and five who can walk – in June last year. Accelerated approval is a process that allows the agency to greenlight treatments before confirmatory data shows they work.
Continued approval for the use of the therapy in Duchenne patients who cannot walk may be contingent on the verification of clinical benefit in a confirmatory trial.
The company, however, said the therapy, Elevidys, should not be used in patients with certain mutations in the DMD gene.
(Reporting by Sriparna Roy and Leroy Leo in Bengaluru; Editing by Shailesh Kuber, Alan Barona and Pooja Desai)
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