YUVIWEL (navepegritide)

The pharmacokinetics of navepegritide, a prodrug releasing CNP following subcutaneous administration, have been investigated at single doses of 0.003 to 0.15 mg/kg in healthy adults, and at weekly doses of 0.006 to 0.1 mg/kg in patients with achondroplasia. Plasma concentrations of navepegritide and CNP released from navepegritide increased proportionally with dose within the range of 0.01 to 0.15 mg/kg. In patients with achondroplasia administered navepegritide 0.1 mg/kg once-weekly, the predic...

The effectiveness of YUVIWEL has been established in a clinical trial of navepegritide consisting of a randomized, double-blind, placebo-controlled 52-week period, followed by a single-arm 52-week OLE period (Trial 1; NCT05598320). Trial 1 enrolled 84 treatment-naïve pediatric patients with genetically confirmed achondroplasia: 57 patients received navepegritide 0.1 mg/kg administered subcutaneously once weekly, and 27 received placebo. The mean age at enrollment was 5.7 years (range: 2 to 12). Forty-five patients (54%) were male, and 39 patients (46%) were female. Overall, 74 patients (88%) w...

Most common adverse reactions (≥ 5%): vomiting, injection-site reaction, pain in extremity, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascendis Pharma at 1-844-442-7236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not re...

None. None. ( 4 )

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. ( 5.1 ) 5.1 Risk of Low Blood Pressure Transient decreases in blood pressure have been reported with a once daily CNP analog. Subjects with hemodynamically significant cardiovascular disease were excluded from participation in navepegritide ...