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Phase II open-label, sequential cohort, dose-escalation study of BMN 111 in children with achondroplasia

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Trial Profile

Phase II open-label, sequential cohort, dose-escalation study of BMN 111 in children with achondroplasia

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Vosoritide (Primary)
  • Indications Achondroplasia
  • Focus Adverse reactions; Proof of concept; Registrational
  • Sponsors BioMarin Pharmaceutical

Most Recent Events

  • 27 Aug 2021 According to a BioMarin Pharmaceutical media release, European Commission (EC) has granted marketing authorization for VOXZOGO (vosoritide), a once daily injection to treat achondroplasia in children from the age of 2 until growth plates are closed, which occurs after puberty when children reach final adult height.
  • 25 Aug 2021 Results assessing pharmacokinetics of vosoritide and relationships between plasma exposure and efficacy, biomarkers, and safety endpoints in phase 2 (NCT02055157) and phase 3 (NCT03197766) studies, published in the Clinical Pharmacokinetics.
  • 25 Jun 2021 According to a BioMarin Pharmaceutical media release, a final approval decision, typically consistent with the CHMP recommendation, is expected from the European Commission in Q3 2021. FDA review of Vosoritide NDA is ongoing, PDUFA target action date set as Nov. 20, 2021

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