European Medicines Agency (EMA) announcements or Sarepta Therapeutics press releases

Sarepta's ($SRPT) ELEVIDYS Gains Expanded FDA Approval for Duchenne Muscular Dystrophy Patients Ages 4 and Above

Jun 20, 2024, 09:04 PM

Sarepta Therapeutics ($SRPT) has announced that the US FDA has expanded the approval of its gene therapy, ELEVIDYS, for Duchenne Muscular Dystrophy (DMD) patients. The label expansion now includes both ambulatory and non-ambulatory patients who are at least 4 years old and have a confirmed mutation in the DMD gene. The non-ambulatory indication is under accelerated approval, while the ambulatory indication has been converted to full approval. This expansion marks a significant milestone for Sarepta Therapeutics and provides broader access to treatment for patients with DMD.