The Food and Drug Administration (FDA) has approved Skytrofa® (lonapegsomatropin-tcgd) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).
Lonapegsomatropin is a pegylated prodrug of the human growth hormone, somatropin, administered as a subcutaneous injection once weekly. It is designed to provide a sustained release of active, unmodified somatropin. The product was previously approved for the treatment of pediatric patients 1 year and older who weigh at least 11.5kg and have growth failure due to inadequate secretion of endogenous growth hormone.
The approval in adult GHD was based on data from the randomized, parallel-arm, placebo-controlled and active controlled foresiGHt trial (ClinicalTrials.gov Identifier: NCT04615273), which included 259 patients aged 23 to 81 years.
Study participants were randomly assigned 1:1:1 to receive lonapegsomatropin once weekly (n=89), placebo once weekly (n=84), or somatropin once daily (n=86). The primary endpoint was the change in trunk percent fat from baseline to week 38 as assessed by dual X-ray absorptiometry.
