BioMarin submits FDA sNDA to expand Voxzogo use to children with hypochondroplasia

Reuters2026/09/09 13:09

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BioMarin filed an sNDA with the FDA to expand VOXZOGO to treat children with hypochondroplasia.
Submission followed Phase 3 CANOPY-HCH-3 data showing a 2.33 cm/year annualized growth-velocity gain vs placebo at 52 weeks.
VOXZOGO is not yet approved for hypochondroplasia; potential launch targeted for 2027 if cleared.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioMarin Pharmaceutical Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202609090905PR_NEWS_USPR_____SF42971) on September 09, 2026, and is solely responsible for the information contained therein.

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BioMarin submits FDA sNDA to expand Voxzogo use to children with hypochondroplasia

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