The recommendation covers children two years of age and older whose epiphyses (growth plates) are not yet closed. The CHMP’s review included data from three randomized, double-blind, placebo-controlled trials and up to three years of open-label extension data. Results from the pivotal ApproaCH trial have been published in JAMA Pediatrics.

A final decision from the European Commission is expected in the fourth quarter of 2026. If approved, Ascendis plans to launch the drug under the brand name Yuviwel in Germany in the first quarter of 2027. The treatment was approved by the US FDA in February 2026.

TransCon CNP is a prodrug of C-type natriuretic peptide designed to provide continuous exposure to active CNP over the weekly dosing interval, counteracting the overactive FGFR3 signaling that causes achondroplasia. The condition is estimated to affect more than 250,000 people worldwide.