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BioMarin's Reports the US FDA’s Acceptance of sNDA for Voxzogo (vosoritide) to Treat Children with Achondroplasia Aged ≤5 Years

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BioMarin's Reports the US FDA’s Acceptance of sNDA for Voxzogo (vosoritide) to Treat Children with Achondroplasia Aged ≤5 Years

Shots:

  • The US FDA has accepted the sNDA for Voxzogo (vosoritide) to treat children aged ≤5yr. with achondroplasia. The US FDA’s decision is expected on Oct 21, 2023
  • The sNDA was based on the results from the P-II clinical trial evaluating Voxzogo which showed similar safety and efficacy profiles in children aged ≤5yr. as compared to ≥5yrs.
  • Voxzogo is a C-type natriuretic peptide (CNP) analog & is approved in the US for pediatric patients with achondroplasia aged ≥5yrs. with open epiphyses. The therapy is also approved in the EU, Brazil, and Australia in children with achondroplasia aged ≥2yrs. & is also approved in Japan in children from birth with achondroplasia with open growth plates

Ref: PRNewswire | Image: BioMarin

Rleated News:- BioMarin’s Voxzogo (vosoritide) Receives US FDA’s Approval for the Treatment of Childrens with Achondroplasia

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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