Skip to Content

Eteplirsen Approval Status

  • FDA approved: No
  • Generic name: eteplirsen
  • Company: Sarepta Therapeutics, Inc.
  • Treatment for: Duchenne Muscular Dystrophy

Eteplirsen is a morpholino antisense oligomer in development for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.

Development Status and FDA Approval Process for eteplirsen

Aug 25, 2015Sarepta Therapeutics Announces FDA Has Filed Eteplirsen NDA for the Potential Treatment of Duchenne Muscular Dystrophy for Patients Amenable to Exon 51 Skipping
Jun 29, 2015Sarepta Therapeutics Completes NDA Submission to FDA for Eteplirsen
Oct 27, 2014Sarepta Therapeutics Announces Regulatory Update on Eteplirsen
Apr 21, 2014Sarepta Therapeutics Announces Plans to Submit NDA to FDA for Eteplirsen for Duchenne Muscular Dystrophy
Nov 12, 2013Sarepta Therapeutics Announces FDA Considers NDA Filing for Eteplirsen Premature in Light of Recent Competitive Drug Failure and Recent DMD Natural History Data
Jul 25, 2013Sarepta Therapeutics Announces Plans to Submit New Drug Application to FDA for Eteplirsen for the Treatment of Duchenne Muscular Dystrophy in First Half of 2014

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.