Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

 Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

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

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: BioMarin Careers

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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