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

The FDA accepted BioMarin's supplemental NDA for full approval of VOXZOGO (vosoritide) in children with achondroplasia, with a PDUFA target action date of February 28, 2027, based on long-term safety and efficacy data including adult height and body proportionality outcomes.

Outcome Details

Supplemental New Drug Application accepted for full approval based on long-term safety and efficacy data from three ongoing studies

Importance:7/10

Sentiment:

0.70

FDA acceptancesupplemental NDAvosoritideachondroplasiapediatric indicationlong-term safety

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Published by PR Newswire Pharma on July 13, 2026 1:05 PM

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