Navepegritide
Drug Details
- Generic Name
- Navepegritide
- Brand Names
- Yuviwel
- Application Number
- NDA219164
- Sponsor
- Ascendis Pharma Endocrinology, Inc.
- NDC Codes
- 3
- Dosage Forms
- KIT
- Routes
- N/A
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE YUVIWEL ® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). YUVIWEL is a C-type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. ( 1 ) This indication is approved under accelerated approval based on an improvement in annualized growth velocity . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ( 1 )