Somapacitan-beco

(Sogroya®)

Somapacitan-beco

Drug updated on 5/17/2024

Dosage FormInjection (subcutaneous; 5 mg/1.5 mL [3.3mg/mL] or 10 mg/1.5 mL [6.7 mg/mL])
Drug ClassHuman 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
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  • Somapacitan-beco (Sogroya) is 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, as well as for replacement in adults with growth hormone deficiency.
  • Three studies were examined, which provided a detailed comparison between Sogroya and other long-acting growth hormones, particularly focusing on safety and effectiveness in pediatric populations with Growth Hormone Deficiency (GHD).
  • In terms of efficacy measured by height velocity and standard deviation scores, Sogroya shows promising results compared to daily growth hormone therapies; however, PEG-LAGH demonstrated better efficacy among the Long Acting Growth Hormones analyzed.
  • A significant advantage of Sogroya over Daily Growth Hormone is its higher adherence rates attributed to once-weekly subcutaneous administration that does not compromise on either safety or efficacy.
  • The risk profile concerning adverse events was found comparable between Sogroya and other treatments including both daily injections and other LAGH formulations; PEG-LAGH slightly reduced this risk suggesting a potentially better safety profile, but differences weren't vast across options including Somapacitan-beco (Sogroya).
  • Studies primarily focused on prepubertal children with GHD indicating that benefits such as improved adherence without compromising on safety or efficacy are especially relevant for this population group.