Voxzogo (vosoritide)
- Region
- 🇪🇺 EU
- Active substance
- vosoritide
- Company
- BioMarin International Limited
- Status
- Authorised
- Therapeutic area
- Achondroplasia
- CHMP opinion
- Thu 24 Jun 2021
- EU approval
- Thu 26 Aug 2021
- Designations
- Orphan
- Application
- EMEA/H/C/005475
- ATC
- M05BX
- Official record
- www.ema.europa.eu
Indication
Voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.
Regulatory milestones
VOXZOGO: PDUFA target action date (hypochondroplasia (HCH))
Biomarin Pharmaceutical Inc (BMRN); sNDA; status: set; "…2026 Total Revenues Increased 32% Y/Y to $1.025 billion; Growth Driven by 44% Increase in Metabolic Conditions Y/Y, and 12% Increase in Skeletal Conditions Y/Y Updates Full-year 2026 Guidance to Reflect Order Timing Uncertainty and Impact of Two Acquired In-process Research and Development (IPR&D) Charges Recently…"; filed 2026-11-02 · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.