Posted by Michael Wonder on 13 Aug 2020
European Medicines Agency validates BioMarin's marketing authorisation application for vosoritide to treat children with achondroplasia
13 August 2020 - Potential first medicine to treat achondroplasia in EU.
BioMarin Pharmaceutical announced today that the EMA validated the Company's marketing authorisation application for vosoritide, an investigational, once daily injection analog of C-type natriuretic peptide for children with achondroplasia, the most common form of disproportionate short stature in humans.
The review will commence on 13 August 2020.
The company remains on track to submit a new drug application to the U.S. FDA in the third quarter of 2020. Vosoritide has orphan drug designation from the FDA and the EMA.
