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

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

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

Shots:

  • The MAA submission is based on ongoing P-III study with material from the to-be-commercialized process and updated 3yrs. P-I/II data. The submission marks the first MAA submission for a gene therapy product targeting any type of hemophilia
  • BioMarin is expected its MAA for Valoctocogene Roxaparvovec to be reviewed under expedited accelerated assessment designation in Jan’2020
  • Valoctocogene roxaparvovec is gene therapy developed utilizing an AAV-factor VIII vector and has received FDA’s BT designation, EMA & FDA’s ODD for hemophilia A with its expected BLA submission to the US FDA by the year-end

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

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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