News
EMA validates MAA for vosoritide to treat children with achondroplasia.- BioMarin
BioMarin Pharmaceutical Inc. announced that the European Medicines Agency (EMA) validated the Company's Marketing Authorization Application (MAA) 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. The MAA review will commence on August 13, 2020.
The company remains on track to submit a New Drug Application (NDA) to the FDA in the third quarter of 2020. Vosoritide has Orphan Drug designation from the FDA and the EMA.
Condition: Achondroplasia
Type: drug
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