Lonapegsomatropin-tcgd

(Skytrofa®)

Skytrofa®

Drug updated on 5/17/2024

Dosage FormInjection (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 ClassHuman 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).

Summary
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  • 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.
  • Two studies were reviewed, comparing Skytrofa with other long-acting growth hormone treatments and daily growth hormone therapies in terms of efficacy and safety.
  • The first study found that lonapegsomatropin showed a mean difference (MD) of 1.335 in height velocity compared with daily GH therapy, indicating higher efficacy in promoting growth among prepubertal children with GHD.
  • However, the second study reported no significant difference between various LAGHs including Skytrofa and daily GH preparations regarding annualized height velocity; quality-of-life outcomes were also comparable across these treatments.
  • In terms of safety profile comparison from both studies, it was concluded that lonapegsomatropin has an acceptable risk ratio for adverse events similar to other LAGHs as well as daily GH therapies.
  • Despite its longer action duration than daily GH therapy, improvement in adherence to treatment regimen or quality-of-life did not show any significant advantage according to findings from the second study.