FDA Conditionally Approves Biomarin's Dwarfism Drug

The FDA has approved BioMarin Pharmaceutical Inc's BMRN Voxzogo (vosoritide) for Injection for achondroplasia.
The approval comes for achondroplasia patients five years and older to increase linear growth in patients with open epiphyses (growth plates).
This indication is approved under accelerated approval based on an improvement in annualized growth velocity (AGV).
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies.
BioMarin intends to use the ongoing open-label extension studies compared to available natural history to fulfill this post-marketing requirement.
Voxzogo is expected to be available in the U.S. by mid-to-late December, and BioMarin will begin the promotion of Voxzogo immediately.
Related Link: Drug For Short-Limbed Dwarfism From Biomarin Wins European Approval.
Price Action: BMRN shares are up 7.40% at $89.06 during the market session on the last check Friday.