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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia, Age 0 to < 60 Months

Trial Profile

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia, Age 0 to < 60 Months

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 24 Oct 2023

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At a glance

  • Drugs Vosoritide (Primary)
  • Indications Achondroplasia
  • Focus Registrational; Therapeutic Use
  • Sponsors BioMarin Pharmaceutical
  • Most Recent Events

    • 20 Oct 2023 According to a BioMarin Pharmaceutical media release, the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for VOXZOGO (vosoritide) to increase linear growth in pediatric patients with achondroplasia with open epiphyses (growth plates). This indication is approved under accelerated approval based on an improvement in annualized growth velocity.
    • 15 Sep 2023 According to a BioMarin Pharmaceutical media release, U.S. Food and Drug Administration PDUFA Target Action Date for Supplemental New Drug Application for VOXZOGO for Children Under 5 is Oct. 21, 2023
    • 15 Sep 2023 According to a BioMarin Pharmaceutical media release, the CHMP based its opinion on data and outcomes from clinical trial 111-206 and (111-208)
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