The USFDA has recently approved somatrogon for treating children aged three years and above with growth attenuation due to growth hormone deficiency (GHD). Somatrogon is a human growth hormone analog that can bind to growth hormone (GH) receptor and activates signal transducer and activator of transcription 5b (STAT5b) signaling pathway. This elevates the serum levels of insulin-like growth factor (IGF-1). GH and IGF-1 facilitate metabolic changes and enhance growth velocity in children with GHD.
The approval was granted based on findings from a phase 3 clinical trial. Clinical trial In the open-label clinical trial, 224 children aged between three and 12 years with GHD were randomized to receive a 0.66 mg/kg dose of somatrogon weekly or 0.034 mg/kg dose of somatropin daily for 52 weeks. Measurement of annualized height velocity at week 52 showed that somatrogon is non-inferior to…
