Ascendis Pharma Reports the US FDA’s sBLA Acceptance of TransCon hGH for Treating Growth Hormone Deficiency
Shots:
- The US FDA has accepted sBLA of TransCon hGH (lonapegsomatropin-tcgd; marketed as Skytrofa for pediatric GHD) to treat adults with growth hormone deficiency (PDUFA: Jul 27, 2025)
- Submission was supported by P-III (foresight) trial comparing weekly TransCon hGH, PBO & daily hGH in adults (n=259; 23-80yrs.), randomized 1:1:1, with GHD
- TransCon hGH showed superiority in reducing trunk fat and increasing lean mass at wk.38 vs PBO. It was safe & well-tolerated & had similar safety to daily hGH, without any study drug-related discontinuations
Ref: Ascendis Pharma | Image: Ascendis Pharma
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