- YUVIWEL was granted orphan drug exclusivity by U.S. FDA to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses
Ascendis Receives Orphan Drug Exclusivity and Launches YUVIWEL® (Navepegritide) in the United States
Ascendis Pharma received FDA orphan drug exclusivity for YUVIWEL® (Navepegritide), a treatment for linear growth in pediatric achondroplasia patients, but the drug's distribution and patient data handling introduce potential supply chain and privacy risks. Healthcare providers, pediatric patients, and data systems managing patient records are affected, raising concerns over unauthorized access, data breaches, and supply chain tampering.