Drug updated on 12/11/2024
| Dosage Form | Injection (subcutaneous; 24 mg/1.2 mL [20 mg/mL], 60 mg/1.2 mL [50 mg/mL]) |
| Drug Class | Human growth hormone analogs |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
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Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Somatrogon demonstrated comparable effectiveness to daily growth hormone (DGH) in terms of height velocity, the mean difference (MD) was 0.105, with a 95% credible interval (CrI) ranging from -0.419 to 0.636 and height standard deviation score (MD = -0.055, 95% CrI: -1.3 to 0.51), indicating it is an effective option for growth hormone deficiency treatment in prepubertal children.
- Polyethylene Glycol-Linked Long-Acting Growth Hormone (PEG-LAGH) showed slightly better outcomes in height velocity (MD = -0.031, 95% CrI: -0.278 to 0.215) and height standard deviation score (MD = -0.15, 95% CrI: -1.1 to 0.66) compared to somatrogon and other Long-Acting Growth Hormone (LAGH) formulations, although all LAGH drugs showed similar overall effectiveness to daily growth hormone.
- Long-acting growth hormone formulations, including somatrogon, were effective and showed comparable outcomes to daily GH for most metrics, suggesting no significant differences in clinical effectiveness among the LAGH options.
- Adverse Events: The safety profile of somatrogon is comparable to DGH, with a risk ratio (RR) of 1.1 (95% CrI: 0.98, 1.2) for adverse events. PEG-LAGH demonstrates a similar RR of 1.00 (95% CrI: 0.82, 1.2), indicating no significant increase in the likelihood of adverse events compared to other long-acting growth hormone (LAGH) formulations.
- General Safety Comparison: LAGH formulations, including somatrogon, somapacitan, and lonapegsomatropin, show similar safety profiles to daily GH. PEG-LAGH may have a slightly better safety profile with a lower risk of adverse events, though no significant safety concerns or subgroup-specific risks were highlighted in the reviewed documents.
- The studies primarily focus on prepubertal children with growth hormone deficiency (GHD), and the findings apply specifically to this population. No significant differences in effectiveness or safety outcomes were noted across other population types or subgroups.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ngenla (somatrogon-ghla) Prescribing Information. | 2023 | Pfizer Inc., New York, NY |