Drug updated on 4/30/2024
| Dosage Form | Injection (subcutaneous: 5 mg/1.5 mL [3.3mg/mL] or 10 mg/1.5 mL [6.7 mg/mL]) |
| Drug Class | Human growth hormone analogs |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
- Indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency.
Summary
- Somapacitan (Sogroya) is indicated for the replacement of endogenous growth hormone in adults with growth hormone deficiency.
- A total of 16 systematic reviews/meta-analyses were reviewed, which compared long-acting growth hormone (LAGH), including somapacitan, to daily growth hormone preparations in children with GHD.
- The studies found no significant difference between LAGH and daily GH treatments regarding mean annualized height velocity, a key measure of efficacy for this indication.
- Other measures of efficacy and safety outcomes also showed comparable results between LAGH formulations like somapacitan and daily GH therapies according to these documents.
- Quality-of-life assessments and adherence rates were similar across both treatment types as per eight studies on adherence and two on quality-of-life included in the review process.
- However, there was an absence of cost-effectiveness data comparing LAGH such as somapacitan to daily GH treatments indicating a need for future research into economic impacts from a healthcare payer's perspective based on these systematic reviews/meta-analyses findings.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Sogroya (somapacitan-beco) Prescribing Information. | 2021 | Novo Nordisk Inc., Plainsboro, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Developments in the management of growth hormone deficiency: clinical utility of somapacitan. | 2024 | Drug Design, Development and Therapy |