Once-Weekly Ngenla Approved for Pediatric Growth Hormone Deficiency

The Food and Drug Administration (FDA) has approved Ngenla^™ (somatrogon-ghla), a once-weekly, human growth hormone analog for the treatment of pediatric patients 3 years of age and older who have growth failure due to inadequate secretion of endogenous growth hormone.

The approval was based on data from a multicenter, randomized, open-label, active-controlled, parallel-group phase 3 study (ClinicalTrials.gov Identifier: NCT02968004), which assessed the efficacy and safety of once-weekly somatrogon to daily injections with somatropin (Genotropin) in 224 treatment-naïve prepubertal pediatric patients with growth hormone deficiency. The primary endpoint was the annualized height velocity at week 52.

Results showed that treatment with somatrogon was noninferior to somatropin, as measured by annual height velocity at week 52 (10.1cm/year vs 9.8cm/year, respectively; mean least squares treatment difference, 0.3 [95% CI, -0.2, 0.9]). The mean height standard deviation score (SDS) at week 52 was -1.94 in the somatrogon arm and -1.99 in the somatropin arm. The mean increase in height SDS from baseline at week 52 was 0.92 in the somatrogon arm and 0.87 in the somatropin arm. 

The safety profile of somatrogon was observed to be comparable to that of somatropin. The most common adverse reactions reported with somatrogon were injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, and oropharyngeal pain.

Ngenla is supplied in single-patient-use disposable prefilled pens and is administered as a subcutaneous injection once weekly. The 24mg/1.2mL pen delivers a dose in 0.2mg increments. The 60mg/1.2mL pen delivers a dose in 0.5mg increments. The product is expected to be available in August 2023.