BioMarin submits FDA sNDA to expand Voxzogo use to children with hypochondroplasia - BMRN News | RalliesBioMarin submits FDA sNDA to expand Voxzogo use to children with hypochondroplasia
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BMRN• FDA filing expands Voxzogo label effort
- BioMarin filed an sNDA with the FDA to expand VOXZOGO to treat children with hypochondroplasia.
- The submission followed Phase 3 CANOPY-HCH-3 data showing a 2.33 cm/year annualized growth-velocity gain versus placebo at 52 weeks.
- VOXZOGO is not yet approved for hypochondroplasia; a potential launch is targeted for 2027 if cleared.
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