Drug updated on 3/28/2024
| Dosage Form | Injection (subcutaneous; 3 mg, 3.6 mg, 4.3 mg, 5.2 mg, 6.3 mg, 7.6 mg, 9.1 mg, 11 mg, 13.3 mg) |
| Drug Class | Human growth hormones |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH).
Summary
- Lonapegsomatropin-tcgd (Skytrofa) is indicated for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone.
- A total of one systematic review/meta-analysis document was reviewed, which included a comparison between long-acting growth hormone (LAGH) preparations like Skytrofa and daily GH in treating children with GHD.
- The meta-analysis incorporated data from 16 studies on efficacy and safety, eight studies on adherence, two studies on quality of life but none reporting cost-effectiveness.
- In terms of efficacy measured by mean annualized height velocity, there were no significant differences found between LAGH formulations including lonapegsomatropin-tcgd (Skytrofa), Eutropin Plus®, Jintrolong® or TransCon compared to daily GH such as Eutropin®, Genotropin® or Jintropin AQ®.
- Safety outcomes along with quality-of-life measures and patient adherence rates were also comparable across all LAGH formulations including lonapegsomatropin-tcgd (Skytrofa) when compared against daily GH treatments according to the analyzed documents.
- Despite some concerns regarding risk bias within the included studies, this analysis suggests that lonapegsomatropin-tcgd's effectiveness is similar to other available options; however further high-quality research is needed for confirmation especially concerning real-world data about mid-to-long term use in larger populations as well as its economic impact from a healthcare payer perspective.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Skytrofa (lonapegsomatropin-tcgd) Prescribing Information. | 2022 | Ascendis Pharma Inc., Palo Alto, CA |