The FDA indicated it could potentially grant an accelerated approval for the therapy, called SRP-9001, initially for use in Duchenne patients aged 4 and 5.
Tag Archive for: SRP-9001
Shares of Sarepta Therapeutics soared 29% premarket on Monday as a backing by the U.S. health regulator’s advisers increased the certainty of an accelerated approval for the company’s gene therapy for a muscle-wasting genetic disorder.
The FDA has accepted Roche and Sarepta’s Biologic License Application for the accelerated approval of SRP-9001 (delandistrogene moxeparvovec), an investigational gene therapy for Duchenne muscular dystrophy (DMD).
The company’s original plan was to not apply to regulators until 2023, but now, it plans to submit the drug to the FDA in the next few months, with plans to launch the drug in mid-2023.