Voxzogo FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 25, 2023.
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 used to increase linear growth in pediatric patients with achondroplasia.
- Voxzogo is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- 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
Further information
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