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Skytrofa FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 26, 2021.

FDA Approved: Yes (First approved August 25, 2021)
Brand name: Skytrofa
Generic name: lonapegsomatropin-tcgd
Dosage form: for Injection
Company: Ascendis Pharma A/S
Treatment for: Pediatric Growth Hormone Deficiency

Skytrofa (lonapegsomatropin-tcgd) is a human growth hormone used once-weekly for the treatment of pediatric growth hormone deficiency.

  • Skytrofa is indicated for the treatment of pediatric patients one year of age and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone.
  • Skytrofa is the first once-weekly treatment for children with growth hormone deficiency. Skytrofa contains lonapegsomatropin-tcgd, a long-acting prodrug of somatropin that releases the same somatropin used in daily human growth hormone therapies.
  • FDA approval of Skytrofa was based on results of the phase 3 heiGHt Trial that compared once-weekly Skytrofa to once-daily somatropin (Genotropin). In comparison, Skytrofa demonstrated higher annualized height velocity (AHV) at week 52, with similar safety and tolerability.
  • Skytrofa is administered once-weekly via subcutaneous injection into the abdomen, buttock, or thighs using the Skytrofa Auto-Injector.
  • Skytrofa may cause serious side effects including hypersensitivity reactions, increased risk of malignancy progression, decreased insulin sensitivity, intracranial hypertension, fluid retention, hypoadrenalism, hypothyroidism, increased risk of slipped capital femoral epiphysis, increased risk of scoliosis progression, and pancreatitis.
  • Common adverse reactions include viral infection, pyrexia, cough, nausea, and vomiting.

Development timeline for Skytrofa

Aug 25, 2021Approval FDA Approves Skytrofa (lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Pediatric Growth Hormone Deficiency

Further information

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