June 20 (Reuters) - The U.S. Food and Drug
Administration on Thursday granted traditional approval to
Sarepta Therapeutics' ( SRPT ) gene therapy for all patients
four years and above with Duchenne muscular dystrophy (DMD) who
can walk.
The FDA in June last year approved the therapy - the
first of its kind for DMD - under its accelerated approval
process, which allows the agency to greenlight treatments before
confirmatory data shows that they work.