Shots:

• The MAA is based on P-III study assessing the efficacy and safety of vosoritide- further supported by the long-term safety and efficacy from the ongoing P-II and P-III extension studies and extensive natural history data
• Following the completion of EMA’s validation- BioMarin expects the initiation of the MAA review to commence in Aug’2020. The company is planning to file NDA to the US FDA in Q3’20
• Vosoritide is an investigational- once-daily injection analog of C-type Natriuretic Peptide (CNP) for children with achondroplasia and has received FDA’s and EMA’s ODD

  Ref: BioMarin | Image: BioMarin