Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency
Shots:
- The approval is based on the P-III heiGHt trial evaluating Skytrofa (qw) vs somatropin in 161 treatment-naïve children ≥aged 1yrs. with GHD who have growth failure due to inadequate secretion of endogenous GH
- The study met its 1EPs i.e., non-inferiority in AHV & showed a higher AHV @52wks., no serious AEs or discontinuations related to Skytrofa were observed
- Skytrofa is the 1st product developed by using Ascendis’ TransCon technology platform & is being evaluated in P-III trials for pediatric GHD in Japan and Greater China. The therapy will be available in the US imminently by a full suite of patient support programs
Click here to read full press release/ article | Ref: GlobeNewswire | Image: PR Newswire