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# FDA Accepts BioMarin Voxzogo New Indication sBLA
- URL: https://www.fdaweb.com/fda-accepts-biomarin-voxzogo-new-indication-sbla/
- Published: 2023-03-08T12:00:00.000Z
- Updated: 2026-09-14T18:18:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153931

FDA has accepted for review a BioMarin sBLA seeking an expanded indication for its Voxzogo (vosoritide) for injection to treat children under age 5 with achondroplasia. The agency set a PDUFA target action date of 10/21.

The company [says](https://www.prnewswire.com/news-releases/fda-accepts-biomarins-supplemental-new-drug-application-to-expand-use-of-voxzogo-vosoritide-for-injection-to-treat-children-with-achondroplasia-under-the-age-of-5-301765021.html?ref=fdaweb.com) the sBLA is supported by results from a Phase 2 trial that demonstrated similar safety and efficacy profiles in children under age 5 as compared to those age 5 and older.

Voxzogo is described as a C-type natriuretic peptide analog that represents a new class of therapy by acting as a positive regulator of the signaling pathway downstream of the fibroblast growth factor receptor gene 3 to promote endochondral bone growth.

The drug received FDA [accelerated approval](https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-improve-growth-children-most-common-form-dwarfism?ref=fdaweb.com) on 10/19/21 to increase linear growth in pediatric patients with achondroplasia who are age 5 and older with open epiphyses.