Sarepta Therapeutics Inc. announced an update regarding its ongoing regulatory review for ELEVIDYS, a gene therapy for Duchenne muscular dystrophy. The Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom has given the green light for dosing to continue uninterrupted in the ENVISION study, which is a global Phase 3 trial. This study involves both non-ambulatory and older ambulatory individuals with Duchenne and is designed as a randomized, double-blind, placebo-controlled trial. Sarepta, a leader in precision genetic medicine for rare diseases, emphasized the significance of this approval as it continues to advance its treatment for Duchenne muscular dystrophy.
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