Is Vosoritide legal in the US?
Yes, FDA approved for children with achondroplasia whose bones are still growing.
Vosoritide is approved by the FDA as Voxzogo (November 2021, accelerated approval) to increase linear growth in children with achondroplasia and open growth plates. Initially for ages 5 and up, the indication was extended in October 2023 to children of all ages with open epiphyses. Continued approval may depend on confirmatory evidence of final adult height. 2 In September 2026 BioMarin said it had submitted a supplemental application to add hypochondroplasia, a related and milder growth condition. The FDA had not decided on it as of October 28, 2026. 4
Yes. It is sold as Voxzogo, under accelerated approval since November 2021. It is for children with achondroplasia and open growth plates. Since October 2023 it covers all ages, down to infancy. Continued approval depends on confirming that faster growth leads to greater adult height. 2
More on Vosoritide
Citations
- Savarirayan 2020, Lancet: Once-daily subcutaneous vosoritide in children with achondroplasia, randomized phase 3 trial doi.org
- FDA 2024: Voxzogo (vosoritide) prescribing information accessdata.fda.gov
- Dauber 2026, NEJM Evidence: a phase 3 trial of vosoritide in children with hypochondroplasia pubmed.ncbi.nlm.nih.gov
- BioMarin 2026: phase 3 hypochondroplasia results published in NEJM Evidence, supplemental application submitted to the FDA biomarin.com
Reference information only, not medical advice. Drawn from the Vosoritide article, fact-checked against the cited sources. No dosing anywhere on this site.