FDA expands approval of Elevydis to include DMD patients ages 4 and up

FDA expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD) for ambulatory and non-ambulatory patients ≥4 years of age with a confirmed DMD gene mutation. Elevidys was previously granted accelerated approval for ambulatory patients 4 through 5 years of age. With the FDA's latest action, Elevidys received traditional approval in ambulatory patients ≥4 years of age and accelerated approval in non-ambulatory patients ≥4 years of age. Tap for more details ...