Delandistrogene moxeparvovec is indicated for:
Population group: only children (1 year - 12 years old)
Delandistrogene moxeparvovec is indicated for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
This indication is approved under accelerated approval based on expression of delandistrogene moxeparvovec micro-dystrophin observed in patients treated with delandistrogene moxeparvovec. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
For this indication, competent medicine agencies globally authorize below treatments (click for details):
Delandistrogene moxeparvovec is contraindicated in the following cases:
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