BioMarin Receives the EMA’s CHMP Positive Opinion to Expand Use of Voxzogo (vosoritide) for Children Aged ≥4 Months with Achondroplasia
Shots:
- The EMA’s CHMP has adopted a positive opinion recommending marketing authorization to expand the indication for Voxzogo to treat children aged ≥4mos. with achondroplasia whose epiphyses (growth plates) are not closed. The EC’s decision is expected in Q4’23
- The opinion was based on the P-II trial (111-206) in children aged 4mos.-5yrs. which showed an improvement in height Z-score of ~0.3 standard deviations across all age groups after 1yr. of treatment. The application also incl, longer-term data from the ongoing extension study (111-208)
- The US FDA’s PDUFA action date for Voxzogo' sNDA is expected on Oct 2023 for children under 5yr. The therapy was approved in the US in children with achondroplasia aged ≥5yr. with open growth plates & in EU aged 2yr.
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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