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
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