🏅 FDA Orphan Designation

Skytrofa

lonapegsomatropin-tcgd

Manufacturer: Ascendis Pharma Endocrinology Division A/S

Indicated for:

Non-acquired isolated growth hormone deficiencyOrphanRare disorder due to inadequate sharing of the placenta

FDA-Approved Indications (2)

Non-acquired isolated growth hormone deficiencyOrphan Designation

replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD)

Rare disorder due to inadequate sharing of the placenta

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)

Population: pediatric patients 1 year and older weighing at least 11.5 kg

Indications & Usage

1 INDICATIONS AND USAGE SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone 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). Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD). SKYTROFA is a human growth hormone indicated for: Pediatric Patients: 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) ( 1 ). Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD) ( 1 ).

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Skytrofa

Ascendis Pharma Endocrinology Division A/S

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.