Novo Nordisk A/S: Once-weekly Sogroya® (somapacitan) is an efficacious and well-tolerated long-acting growth hormone in children with growth disorders: results from REAL8 phase 3 basket study presented at the joint Congress of ESPE and ESE

Core Insights - The phase 3 REAL8 study demonstrated that once-weekly Sogroya (somapacitan) is non-inferior to once-daily Norditropin (somatropin) in improving yearly growth rate in pre-pubertal children with growth disorders [1][6][9] - Sogroya showed superiority in height velocity for children with Noonan syndrome and compared favorably against lower doses of daily growth hormone in children born small for gestational age [1][7][8] Group 1: Study Results - Sogroya was well-tolerated with no safety issues compared to daily growth hormone, and IGF-1 response was similar between the two treatments [2][6] - The trial achieved primary endpoints across three sub-studies, confirming the efficacy of once-weekly Sogroya [3][6] - In children born SGA, Sogroya had a mean height velocity of 11.0 cm/year compared to 9.4 cm/year for a lower dose of somatropin, and was non-inferior to a higher dose [7][8] Group 2: Treatment Adherence - Non-adherence to daily growth hormone treatment is a significant issue, with missed doses leading to substantial height differences over time [4][5] - The once-weekly administration of Sogroya aims to reduce treatment burden and improve adherence, potentially enhancing health outcomes for children [5][6] Group 3: Regulatory and Developmental Aspects - The indications for Sogroya (SGA, Noonan syndrome, and idiopathic short stature) have been submitted for regulatory review in the EU and US based on REAL8 and REAL9 data [8][9] - REAL8 employs an innovative basket trial design, allowing for efficient clinical development across multiple related indications [10][11]