Shots:
- 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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