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The US FDA has accepted an sNDA for Voxzogo (vosoritide) for full approval in children with achondroplasia (PDUFA: Feb. 28, 2027)
The sNDA was supported by long-term safety & efficacy data from the ongoing 111-205, 111-208, & 111-302 studies, demonstrating clinically meaningful improvements in growth & key skeletal measures, incl. body proportionality & arm span
Voxzogo is a C-type natriuretic peptide (CNP) analog that promotes endochondral bone growth by positively regulating signaling downstream of FGFR3. It received FDA accelerated approval in 2021
Ref: PRnewswire | Image: BioMarin | Press Release
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The post BioMarin Reports the US FDA’s sNDA Acceptance for Full Approval of Voxzogo in Achondroplasia appeared first on PharmaShots.
BioMarin Reports the US FDA’s sNDA Acceptance for Full Approval of Voxzogo in Achondroplasia | PharmaVoice