BioMarin Reports the Submission of MAA to EMA for Vosoritide to Treat Children with Achondroplasia

 BioMarin Reports the Submission of MAA to EMA for Vosoritide to Treat Children with Achondroplasia

BioMarin Reports Submission of MAA to EMA for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A

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

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

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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