The Food and Drug Administration (FDA) has approved Skytrofa\u00ae (lonapegsomatropin-tcgd) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n","protected":false},"excerpt":{"rendered":"
The Food and Drug Administration (FDA) has approved Skytrofa\u00ae (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 […]<\/p>\n","protected":false},"author":2,"featured_media":1375,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[40],"tags":[311],"class_list":{"0":"post-1374","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","8":"tag-fda-approves-skytrofa-for-adults-with-growth-hormone-deficiency"},"yoast_head":"\n