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Vosoritide FDA Approval Status

Last updated by Judith Stewart, BPharm on Sep 14, 2020.

FDA Approved: No
Generic name: vosoritide
Company: BioMarin Pharmaceutical Inc.
Treatment for: Achondroplasia

Vosoritide is an investigational, once daily injection analog of C-type Natriuretic Peptide (CNP) in development for the treatment of children with achondroplasia.

Development Timeline for vosoritide

DateArticle
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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