Posted by Michael Wonder on 28 Feb 2026
FDA approves once weekly Yuwivel (navepegritide) for children with achondroplasia aged 2 years and older
27 February 2026 - Rare paediatric disease priority review voucher granted in connection with approval.
Ascendis Pharma today announced that the US FDA has granted approval under the FDA’s accelerated approval program for YUVIWEL® (navepegritide; developed as TransCon® CNP), the first and only once weekly treatment indicated to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses and the only one to provide continuous systemic exposure to CNP over the weekly dosing interval.
