BLA 761177, held by Ascendis Pharma Encocrinology Div A/S. Lonapegsomatropin-Tcgd.
As of Nov 13, 2026, BLA 761177 (Skytrofa), held by Ascendis Pharma Encocrinology Div A/S, was first approved by FDA on Aug 25, 2021, with 3 approved supplements and 0 published complete response letters.
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). Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 2025 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Aug 25, 2021 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Skytrofa3MG · injectable;injection | Lonapegsomatropin-Tcgd | Rx |
| Skytrofa3.6MG · injectable;injection | Lonapegsomatropin-Tcgd | Rx |
| Skytrofa4.3MG · injectable;injection | Lonapegsomatropin-Tcgd | Rx |
| Skytrofa5.2MG · injectable;injection | Lonapegsomatropin-Tcgd | Rx |
| Skytrofa6.3MG · injectable;injection | Lonapegsomatropin-Tcgd | Rx |
| Skytrofa7.6MG · injectable;injection | Lonapegsomatropin-Tcgd | Rx |
| Skytrofa9.1MG · injectable;injection | Lonapegsomatropin-Tcgd | Rx |
| Skytrofa11MG · injectable;injection | Lonapegsomatropin-Tcgd | Rx |
| Skytrofa13.3MG · injectable;injection | Lonapegsomatropin-Tcgd | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 2025 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jul 9, 2025 | Supplement 9Labeling · Standard review | Approved | |
| Oct 20, 2022 | Supplement 1Labeling · Standard review | Approved | |
| Aug 25, 2021 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
