==Sarepta Therapeutics (SRPT) : expanded FDA approval of ELEVIDYS to Duchenne Muscular Dystrophy patients

 

Sarepta Therapeutics announces expanded FDA approval of ELEVIDYS to Duchenne Muscular Dystrophy patients

• FDA grants traditional approval to ELEVIDYS for ambulatory Duchenne patients. FDA grants accelerated approval to ELEVIDYS for non-ambulatory Duchenne patients.
• Consistent with the accelerated approval pathway, Sarepta has committed to conduct and submit the results of a randomized, controlled trial to verify and confirm the clinical benefit of ELEVIDYS in patients with Duchenne muscular dystrophy who are non-ambulatory. ENVISION (Study SRP-9001-303), a global, randomized, double-blind, placebo-controlled Phase 3 study of ELEVIDYS in non-ambulatory and older ambulatory individuals with Duchenne, is underway and intended to serve as this postmarketing requirement.