U.S. Food and Drug Administration Accepts BioMarin's Supplemental New Drug Application for Full Approval of VOXZOGO® (vosoritide) for Children With Achondroplasia
NDA FilingVOXZOGOPositive
AI Analysis
Summary
BioMarin's supplemental NDA for VOXZOGO full approval in children with achondroplasia has been accepted by the FDA, with a PDUFA target decision date of February 28, 2027. The application is supported by long-term safety and efficacy data including adult height, body proportionality, and arm span measurements from three ongoing studies.
Clinical Trial Data
Primary Endpoint
Met
Outcome Details
Supplemental New Drug Application accepted for full approval review
Importance:8/10
Sentiment:
0.70
FDASPAachondroplasiapediatriclong-term databody proportionality
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Published by PR Newswire Biotech on July 13, 2026 1:05 PM