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August 27, 2021August 25, 2021 – The U.S. FDA has approved Skytrofa® (lonapegsomatropin-tcgd) to treat pediatric patients who are at least one year old, weigh at least 11.5kg (25.4 pounds), and have growth failure due to inadequate secretion of endogenous growth hormone.
- The recommended dose is 0.24mg/kg of the patient's body weight, given once weekly using an auto-injector. The dose may need to be adjusted based on individual patient factors. Skytrofa can be given at home by family members trained in proper administration technique.
- Manufactured by Ascendis Pharma, Skytrofa is the first FDA-approved treatment for pediatric growth hormone deficiency that is given once a week. Similar therapies, which are a current standard of care, are typically given once daily.
- Skytrofa is anticipated to launch in the near future.