Navepegritide

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. 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.

CNP released from navepegritide has the same receptor binding affinity and activity as endogenous CNP. CNP binds to natriuretic peptide receptor-B (NPR-B), which inhibits the mitogen activated protein kinase signaling (MAPK) pathway. Achondroplasia is caused by a gain-of-function variant in the fibroblast growth factor receptor 3 (FGFR3) leading to overactive downstream signaling. The overly active FGFR3 inhibits endochondral ossification leading to short stature and skeletal dysplasia. Like endogenous CNP, CNP released from navepegritide binds to NPR-B, stimulating an increase in cyclic guanosine monophosphate (cGMP) and signaling through protein kinase G, resulting in an inhibition of the MAPK signaling pathway and thereby antagonizing the overactive FGFR3 signaling in achondroplasia.

Administer once-weekly by subcutaneous injection. Dosage is based on body weight. Periodically monitor growth and adjust dose according to body weight. Discontinue when no further growth potential, as indicated by epiphyseal closure. See Full Prescribing Information for instructions on preparation and administration.

None. None.

Risk of Low Blood Pressure: Transient decreases in blood pressure have been reported with a once daily CNP analog. Advise patients to contact their healthcare provider if they experience symptoms of decreased blood pressure while being treated with YUVIWEL.

Most common adverse reactions (≥ 5%): vomiting, injection-site reaction, pain in extremity, and nausea.

Store YUVIWEL refrigerated between 2°C to 8°C (36°F to 46°F). Do not freeze. YUVIWEL can also be stored at room temperature up to 30°C (86°F) for up to 6 months and can be returned to refrigeration within the 6 months. Do not use YUVIWEL beyond the expiration date or 6 months after the date it was first removed from refrigeration (whichever is earlier). Store in the original packaging until time of use to protect from light. Reconstituted YUVIWEL can be stored at room temperature up to 30°C (86°F) for up to 4 hours.