Drug updated on 9/4/2024
| 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
- 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 (GH).
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Summary
- Skytrofa (lonapegsomatropin-tcgd) 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 (GH).
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- PEG-LAGH showed superior efficacy in height velocity compared to somatrogon, somapacitan, and lonapegsomatropin in prepubertal children with GHD. Mean differences were: PEG-LAGH vs somatrogon: 0.105 (95% CrI: -0.419, 0.636); PEG-LAGH vs somapacitan: 0.802 (95% CrI: -0.451, 2.068); PEG-LAGH vs lonapegsomatropin: 1.335 (95% CrI: -0.3, 2.989).
- In terms of height standard deviation scores, PEG-LAGH demonstrated slightly better improvement compared to somatrogon (MD = -0.055, 95% CrI: -1.3, 0.51) and somapacitan (MD = 0.22, 95% CrI: -0.91, 1.3) in prepubertal children with GHD.
- PEG-LAGH reduced the risk of adverse events (RR: 1.00, 95% CrI: 0.82, 1.2) compared to somatrogon (RR: 1.1, 95% CrI: 0.98, 1.2), somapacitan (RR: 1.1, 95% CrI: 0.96, 1.4), and lonapegsomatropin (RR: 1.1, 95% CrI: 0.91, 1.3). The safety profile of PEG-LAGH was comparable to daily growth hormone (DGH).
- Safety outcomes were comparable across all LAGH formulations and daily GH in children with growth hormone deficiency (GHD), with no significant differences in safety profiles reported.
- The reviewed studies focused on prepubertal children with growth hormone deficiency (GHD), with no additional population types or subgroups mentioned.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Skytrofa (lonapegsomatropin-tcgd) Prescribing Information. | 2022 | Ascendis Pharma Inc., Palo Alto, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Spotlight on lonapegsomatropin once-weekly injection and its potential in the treatment of growth hormone deficiency in pediatric patients. | 2022 | Drug design, Development and Therapy |