Shots:
- FDA granted accelerated approval to Yuviwel (navepegritide, QW) to increase linear growth in children (≥2yrs.) with achondroplasia & open epiphyses; commercially available by Q2’26
- Approval was based on extensive clinical data, incl. 3 PBO-controlled trials plus up to 3yrs. of OLE data, with the pivotal ApproaCH results published in JAMA Pediatrics
- Continued approval may require confirmatory trials to verify clinical benefit beyond AGV improvement, and the FDA also granted a Rare Pediatric Disease PRV with the approval
Ref: Ascendis | Image: Ascendis | Press Release
Related News: X4 Pharmaceuticals’ Xolremdi (Mavorixafor) Receives the CHMP Positive Opinion for WHIM Syndrome
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