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Somapacitan-beco

(Sogroya®)

Sogroya®

Drug updated on 9/4/2024

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.

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Summary
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  • Sogroya (somapacitan-beco) 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, and for the replacement of endogenous growth hormone in adults with growth hormone deficiency.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Somapacitan showed comparable effectiveness to daily growth hormones (DGH) in prepubertal children with Growth Hormone Deficiency (GHD) for key outcomes, including height velocity (MD = 0.04, p = 0.96), height standard deviation scores (Height SDs) (MD = 0.11, p = 0.69), IGF-I SDs (MD = 0.06, p = 0.70), and the bone age vs. chronological age ratio (BA vs. CA) (MD = 0.67, p = 0.70).
  • Compared to other long-acting growth hormones (LAGH), somapacitan had a mean difference of 0.802 (95% CrI: -0.451, 2.068) for height velocity and 0.22 (95% CrI: -0.91, 1.3) for height SDs. PEG-LAGH demonstrated better height velocity and height SDs than somapacitan.
  • Somapacitan’s effectiveness was intermediate when compared to somatrogon and lonapegsomatropin in improving height velocity and height SDs in the same population.
  • Somapacitan exhibited a comparable risk ratio (RR: 1.1, 95% CrI: 0.96, 1.4) for adverse events compared to PEG-LAGH and other long-acting growth hormones (LAGH), with similar adverse events as daily growth hormones (DGH), though specific adverse event types were not detailed.
  • Injection site reactions were mentioned in safety assessments for somapacitan, but specific data were not provided.
  • The primary population across all studies was prepubertal children with growth hormone deficiency (GHD), with subgroup analyses indicating no significant differences in emotional well-being, physical function, or social well-being scores; adherence rates were higher for somapacitan (95%) compared to daily growth hormones (DGH) (88%), with no significant differences in quality of life (QoL) among subgroups.