Ascendis Pharma announces FDA approval of Yuviwel

Ascendis Pharma (ASND) announced that the U.S. FDA has granted approval under the FDA’s Accelerated Approval Program for Yuviwel, 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. Continued approval for this indication, which was based on an improvement in annualized growth velocity, may be contingent upon verification and description of clinical benefit in confirmatory trial. Commercial availability is expected during the early part of Q2.