BioMarin Report Results of Vosoritide in P-III OLE Study for the Treatment of Children with Achondroplasia at ENDO 2021

 BioMarin Report Results of Vosoritide in P-III OLE Study for the Treatment of Children with Achondroplasia at ENDO 2021

BioMarin Report Results of Vosoritide in P-III OLE Study for the Treatment of Children with Achondroplasia at ENDO 2021

Shots:

  • The ongoing P-III OLE study involves assessing Vosoritide (15 mcg/kg) vs PBO in 119 children with achondroplasia. The CHMP opinion is expected in Europe in June 2021
  • The results demonstrated increased AGV, baseline mean AGV of 4.28 cm/year, sustained restoration of a major portion of the growing deficit and improved height z-score through the second year of treatment, Similar efficacy after one year of treatment, crossed over to treatment with baseline mean AGV of 3.99 cm/year, mean AGV was 5.65 cm/year
  • Vosoritide has also received ODD from FDA and EMA for the treatment of children with achondroplasia. The NDA filing is under review from the FDA with a PDUFA date of August 20, 2021

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

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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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