European Medicines Agency validates application for extension of indication for Vozogo (vosoritide) for injection to treat children with achondroplasia under the age of 2

BioMarin

4 January 2023 - BioMarin submits supplemental new drug application to US FDA to expand label to treat children with achondroplasia under the age of 5.

BioMarin Pharmaceutical announced today that the EMA validated its Type II variation application to extend the indication for Voxzogo (vosoritide) for injection to treat children with achondroplasia under the age of 2.

Read BioMarin press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Paediatrics , Dossier