FDA Approves Ngenla (somatrogon-ghla) for Pediatric Growth Hormone Deficiency
The FDA has approved Ngenla (somatrogon-ghla), a once-weekly human growth hormone analog, for the treatment of pediatric patients aged 3 years and older with growth failure due to inadequate secretion of endogenous growth hormone. This approval offers a less frequent dosing option compared to daily growth hormone injections, which may improve adherence in children with growth hormone deficiency. The approval was supported by a phase 3 study in 224 treatment-naïve prepubertal children, which demonstrated that once-weekly Ngenla 0.66 mg/kg produced an annualized height velocity of 10.1 cm/year at 52 weeks, similar to the 9.8 cm/year seen with daily somatropin 0.034 mg/kg/day. Clinicians should note that Ngenla requires a fundoscopic examination before initiation to rule out preexisting papilledema, and dosing should be individualized based on growth response.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
Ngenla is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.
- Recommended dosage: 0.66 mg/kg based on actual body weight administered once weekly by subcutaneous injection. - Administer on the same day each week, at any time of day, in the abdomen, thighs, buttocks, or upper arms with weekly rotation of injection site. - Individualize dosage based on growth response. - When switching from daily growth hormone, initiate Ngenla on the day following the last daily injection. - If a dose is missed, administer as soon as possible within 3 days; if more than 3 days have passed, skip the missed dose and resume regular schedule. - Perform fundoscopic examination before initiating treatment to exclude preexisting papilledema.
A phase 3, multicenter, randomized, open-label, active-controlled study (NCT02968004) in 224 treatment-naïve prepubertal pediatric subjects with GHD. Subjects received either Ngenla 0.66 mg/kg/week (n=109) or daily somatropin 0.034 mg/kg/day (n=115). At Week 52, annualized height velocity was 10.1 cm/year for Ngenla and 9.8 cm/year for daily somatropin (treatment difference 0.3 cm/year; 95% CI -0.2, 0.9). Mean height SDS at Week 52 was -1.94 for Ngenla and -1.99 for daily somatropin; mean increase from baseline was 0.92 and 0.87, respectively.
Contraindicated in acute critical illness after open heart surgery, abdominal surgery, or multiple accidental trauma. Additional contraindications and warnings not fully reported in label.
Ngenla provides a once-weekly alternative to daily growth hormone injections for pediatric patients aged 3 years and older with growth failure due to GHD. It offers comparable efficacy in height velocity and may improve treatment adherence. Clinicians should individualize dosing and monitor growth response.
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