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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

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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: 21 Mar 2025

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At a glance

  • Drugs Vosoritide (Primary)
  • Indications Achondroplasia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors BioMarin Pharmaceutical

Most Recent Events

  • 20 Mar 2025 According to a BioMarin Pharmaceutical media release, positive new data from this study will be presented at the 2025 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting in Los Angeles.
  • 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

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