Ascendis Pharma announces FDA approved SKYTROFA

Ascendis Pharma (ASND) announced that the U.S. Food & Drug Administration, FDA, has approved SKYTROFA for the replacement of endogenous growth hormone in adults with growth hormone deficiency, a rare disorder resulting from decreased or total loss of growth hormone production. Lonapegsomatropin is a prodrug of somatropin administered once weekly, providing sustained release of active, unmodified somatropin. The FDA’s approval of SKYTROFA for adult GHD was based on results from foresiGHt, a Phase 3 randomized, parallel-arm, placebo-controlled and active-controlled clinical trial that compared the efficacy and safety of weekly TransCon hGH with weekly placebo and daily somatropin in adults with GHD.