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Voxzogo FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 19, 2021.

FDA Approved: Yes (First approved November 19, 2021)
Brand name: Voxzogo
Generic name: vosoritide
Dosage form: Lyophilized Powder for Injection
Company: BioMarin Pharmaceutical Inc.
Treatment for: Achondroplasia

Voxzogo (vosoritide) is a C type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients with achondroplasia.

  • Achondroplasia is a genetic disorder of bone growth characterized by disproportionate short stature (dwarfism) and disordered architecture in the long bones, spine, face and base of the skull. It is caused by impaired endochondral bone growth due to a gain of function mutation in fibroblast growth factor receptor 3 gene (FGFR3).
  • Voxzogo works as a positive regulator of the signaling pathway downstream of FGFR3 to promote endochondral bone growth.
  • Voxzogo is administered via subcutaneous injection once daily.
  • Voxzogo may cause serious adverse reactions including a risk of low blood pressure. To reduce this risk, patients should be well hydrated and have adequate food intake prior to receiving Voxzogo.
  • Common adverse reactions include injection site erythema, injection site swelling, vomiting, injection site urticaria, arthralgia, decreased blood pressure, and gastroenteritis.

 

 

Development timeline for Voxzogo

DateArticle
Nov 19, 2021Approval FDA Approves Voxzogo (vosoritide) to Increase Linear Growth in Children with Achondroplasia
Mar 20, 2021BioMarin Announces Oral Presentation at ENDO2021, the Endocrine Society's Annual Meeting, with Data Demonstrating 2 Years of Treatment Benefit in Children with Achondroplasia Treated with Vosoritide
Nov  2, 2020FDA Accepts BioMarin's New Drug Application for Vosoritide to Treat Children with Achondroplasia
Aug 20, 2020BioMarin Submits New Drug Application to U.S. Food and Drug Administration for Vosoritide to Treat Children with Achondroplasia
Dec 16, 2019BioMarin Announces Positive Final Results from Placebo-Controlled Phase 3 Data in Children with Achondroplasia Treated with Vosoritide
Jun 18, 2019BioMarin Announces New England Journal of Medicine Publishes Vosoritide Phase 2 Study Showing Sustained Annualized Growth Up to 42 Months in Children with Achondroplasia

Further information

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