Drug updated on 4/16/2024
| Dosage Form | Injection (subcutaneous; 24 mg/1.2 mL [20 mg/mL] single-patient-use prefilled pen that delivers a dose in 0.2 mg increments, 60 mg/1.2 mL [50 mg/mL] single-patient-use prefilled pen that delivers a dose in 0.5 mg increments) |
| Drug Class | Human growth hormone analogs |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone
Summary
- Somatrogon-ghla (Ngenla) is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
- One systematic review/meta-analysis was reviewed, which compared Ngenla with other long-acting growth hormone preparations and daily treatments in children with Growth Hormone Deficiency (GHD).
- The efficacy comparison showed no significant difference between Ngenla and conventional daily Growth Hormone therapies in terms of height velocity outcomes.
- In terms of safety, adherence, quality of life indicators, all Long Acting Growth Hormones including Ngenla were found similar to daily GH based on the studies reviewed.
- The study specifically targeted children with GHD but did not delineate findings across different subgroups within this population such as age brackets or severity levels.
- The review acknowledged limitations like risk bias across included studies and the absence of real-world data addressing long-term adherence & Quality Of Life; it called for future high-quality research emphasizing the economic impact from a healthcare payer perspective.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ngenla (somatrogon-ghla) Prescribing Information. | 2023 | Pfizer Inc., New York, NY |