Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency

August 27, 2021 Auto Bot approval, FDA, regulatory 0

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

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