Drug updated on 10/25/2024
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).
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Lonapegsomatropin (Skytrofa) in Prepubertal Children with GHD: At 52 weeks, lonapegsomatropin demonstrated comparable efficacy in height velocity and height standard deviation score (SDS) to other long-acting growth hormones like somatrogon and somapacitan. Lonapegsomatropin (PEG-LAGH (mean difference [MD]: - 0.031, 95% credibility interval [CrI]: - 0.278, 0.215)) showed slight advantages in height velocity (MD 1.335) and height SDS compared to somatrogon and somapacitan, although results were variable with wide confidence intervals.
- Safety of Lonapegsomatropin: Lonapegsomatropin was generally well tolerated, with no significant difference in the risk of adverse events compared to somatrogon, somapacitan, or daily growth hormone (GH). Lonapegsomatropin demonstrated a slightly lower risk of adverse events compared to somatrogon (RR (somatrogon, RR: 1.1, 95% CrI: 0.98, 1.2; somapacitan, RR: 1.1, 95% CrI: 0.96, 1.4; lonapegsomatropin, RR, 1.1, 95% CrI: 0.91, 1.3) 1.1) and somapacitan (RR 1.1). Injection site pain was specifically noted for somatrogon in one study.
- Specific Safety Concern for Somatrogon: Injection site pain was specifically noted for somatrogon but was not highlighted for lonapegsomatropin.
- The population of focus consisted of prepubertal children with growth hormone deficiency (GHD), with no significant differences in effectiveness outcomes noted across specific subgroups. There were no additional findings explicitly related to subgroups based on age, gender, or comorbid conditions.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Skytrofa (lonapegsomatropin-tcgd) Prescribing Information. | 2024 | Ascendis Pharma Inc., Palo Alto, CA |
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 |