BioMarin plans regulatory submissions in Q3 2020 at FDA and EMA for vosoritide to treat children with achondroplasia.
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BioMarin Pharmaceutical announced that data from the open-label long-term extension of the Phase III study of 15 µg/kg dose of BMN 111 (vosoritide) for the treatment of achondroplasia showed that children maintained an increase in Annual Growth Velocity (AGV) through the second year of continuous treatment with vosoritide.
BioMarin Pharmaceutical Inc. announced that the FDA has accepted the New Drug Application (NDA) for vosoritide, an investigational, once daily injection analog of C-type Natriuretic Peptide (CNP) for children with achondroplasia, the most common form of disproportionate short stature in humans.
BioMarin Pharmaceutical Inc. announced that The Lancet has published online results from a randomized, double-blind, phase III, placebo-controlled, multicenter trial for vosoritide , an investigational analog of C-type Natriuretic Peptide (CNP), in children aged 5 to 18 years with achondroplasia.