Shots:

• The acceptance marks the first marketing application accepted for achondroplasia in the US with an anticipated PDUFA date as of Aug 20- 2021. The US FDA is not planning to hold an advisory committee meeting to discuss the application
• Additionally- the company is expecting to complete enrollment in a P-II study assessing vosoritide in ~70 infants and young children with achondroplasia- aged 0-<60mos.- for 52wks.
• Vosoritide (qd) is an investigational injection analog of C-type Natriuretic Peptide (CNP) for children with achondroplasia and has received the US FDA’s & EMA’s ODD for the same

  Ref: PRNewswire | Image: BioMarin Careers