Vosoritide U.S. label context · version 1
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What does the U.S. product label say?
Voxzogo · Read September 15, 2026 · Preserved label summary 1
Which population and use does the label cover?
The cited U.S. label covers increased linear growth in pediatric patients with achondroplasia and open growth plates. Accelerated approval is based on annualized growth velocity; continued approval depends on confirmation of clinical benefit. Label: 1 ↗
What clinical outcome supported the label?
The label describes a 52-week randomized placebo-controlled study in 121 children with achondroplasia. The adjusted difference in annualized growth velocity was 1.57 cm per year in favor of vosoritide. This growth-rate endpoint does not establish final adult height or every functional outcome; extension participants overlap the original trial. Label: 14 ↗
Which safety limits matter?
The label describes transient decreases in blood pressure. Its growth-velocity finding is not itself proof of improved adult height or all functional outcomes. Label: 1, 5, 14 ↗
Label edition and source pins
U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.
VOXZOGO (vosoritide) kit · SPL version 16 · published 2025-11-26
Label ZIP SHA-256: 01bd93709f678ebf940f87c036fa3fe74fef3e457891d243c5c4e759d0253924. Extracted XML SHA-256: 3faeddb93511f0bc64c4bd0e70f367ced4dcb0b45a2b9864ad5ad67026080e89.