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Viltepso FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved August 12, 2020)
Brand name: Viltepso
Generic name: viltolarsen
Dosage form: Injection
Company: NS Pharma, Inc.
Treatment for: Duchenne Muscular Dystrophy

Viltepso (viltolarsen) is an antisense oliogonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

  • This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with Viltepso. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Viltepso is administered as an intravenous infusion over 60 minutes.
  • Viltepso has the potential to cause kidney toxicity. Kidney function should be monitored.
  • Common adverse reactions (incidence ≥15% in include upper respiratory tract infection, injection site reaction, cough, and pyrexia.

Development timeline for Viltepso

Aug 12, 2020Approval FDA Approves Viltepso (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy in Patients Amenable to Exon 53 Skipping Therapy
Feb  7, 2020NDA Accepted for Filing by the FDA for Antisense Oligonucleotide Viltolarsen (NS-065/NCNP-01)

Further information

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