Drug updated on 12/11/2024
| Dosage Form | Injection (subcutaneous; 5 mg/1.5 mL [3.3 mg/mL], 10 mg/1.5 mL [6.7 mg/mL], 15 mg/1.5 mL [10 mg/mL]) |
| Drug Class | Human growth hormone analogs |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for pediatric Patients: Treatment of pediatric patients aged 2
- 5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone
- Indicated for Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency
Latest News
Summary
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Growth Outcomes in Children with Growth Hormone Deficiency (GHD): At 52 weeks, somapacitan showed comparable efficacy to somatrogon, lonapegsomatropin, and daily Growth Hormone (GH) for growth outcomes such as annualized height velocity and height velocity Standard Deviation Score (SDS). Polyethylene Glycol-Linked Long-Acting Growth Hormone (PEG-LAGH) demonstrated slightly better height velocity (Mean Difference [MD]: -0.031, 95% Confidence Interval [CI]: -0.278, 0.215) and height SDS improvement (MD: -0.15, 95% CI: -1.1, 0.66) than somapacitan.
- Comparative Efficacy with Norditropin: In children, Norditropin at 0.034 mg/kg/day showed significantly better height velocity (MD: -2.01, 95% CI: -3.7 to -2.12, P < 0.00001) and height velocity SDS (MD: -3.61, 95% CI: -5.06 to -2.16, P < 0.00001) compared to somapacitan at 0.04 mg/kg/day. In adults, somapacitan resulted in a higher Insulin-Like Growth Factor 1 (IGF-1) SDS (MD: 0.25, 95% CI: 0.02–0.48, P = 0.03) than Norditropin.
- Adherence and Treatment Efficacy: Somapacitan had similar growth efficacy to daily GH in prepubertal children and demonstrated significantly higher adherence (95% vs. 88%; Odds Ratio [OR]: 3.02; P = 0.03).
- Safety Profiles: Somapacitan, somatrogon, and lonapegsomatropin were generally well-tolerated, with safety profiles comparable to daily GH. A notable exception was injection site pain observed with somatrogon. In adults, rash was less prevalent in the Sogroya group compared to Norditropin (OR: 0.1, 95% CI: 0.04–0.27, P < 0.00001).
- Risk of Adverse Events: PEG-LAGH reduced the risk of adverse events compared to other Long-Acting Growth Hormones (LAGHs), including somapacitan (Relative Risk [RR]: 1.1, 95% Credible Interval [CrI]: 0.96–1.4), and was comparable to daily GH in adverse event profiles. Moderate confidence was noted in somapacitan-related severe adverse events, with heterogeneity >50%.
- Population and Subgroup Analyses: Prepubertal children and adults with GHD were identified as key groups studied, showing comparable growth outcomes across treatments in children, differences in IGF-1 SDS in adults, and higher adherence rates with somapacitan (OR: 3.02; P = 0.03). Pharmacokinetic/Pharmacodynamic (PK/PD) modeling highlighted body weight as a determinant of GH exposure and IGF-I response, influencing treatment outcomes across both groups.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Sogroya (somapacitan-beco) Prescribing Information. | 2023 | Novo Nordisk Inc., NJ, USA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Guidance for the treatment of adult growth hormone deficiency with somapacitan, a long-acting growth hormone preparation. | 2022 | Frontiers in Endocrinology |