BioMarin Pharmaceutical (NSDQ:BMRN) announced today that the FDA granted accelerated approval for its Voxzogo for injection.
San Rafael, California-based BioMarin’s Voxzogo (vosoritide) injection has indication to increase linear growth in pediatric patients with achondroplasia (a form of dwarfism) five years of age and older with open epiphysis (growth plates). Continued approval may be contingent upon verification and description of clinical benefit in confirmatory studies, with BioMarin intending to use the ongoing open-label extension studies compared to available natural history.
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