Skip to Content

Drisapersen Approval Status

Drisapersen is an investigational antisense oligonucleotide in development for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping.

Development Status and FDA Approval Process for drisapersen

Oct 15, 2015BioMarin Announces FDA Advisory Committee to Review Drisapersen for Treatment of Patients With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
Aug 19, 2015BioMarin Receives Rare Pediatric Disease Designation From FDA for Drisapersen for the Potential Treatment of Duchenne Muscular Dystrophy
Jun 29, 2015BioMarin Announces FDA Accepts Drisapersen NDA for Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
Apr 27, 2015BioMarin Completes Rolling NDA Submission to FDA for Drisapersen for Duchenne Muscular Dystrophy
Oct 10, 2014Prosensa Begins NDA Submission for Drisapersen to treat Duchenne Muscular Dystrophy
Jun  3, 2014Prosensa Announces Regulatory Path Forward for Drisapersen as a Potential Treatment for DMD

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.