hrp0098p1-68 | Growth and Syndromes 1 | ESPE2024

Impact of Idiopathic Short Stature (ISS) on children’s well-being.

Juul Anders , Linglart Agnes , Højby Rasmussen Michael , Lund Leunbach Tina , Pietropoli Alberto , Pedersen Mikkel , de Fries Jensen Lasse

Introduction: Idiopathic short stature (ISS) is characterized by a reduced height (at least 2 standard deviation scores [SDS]) from expected norms based on age, sex, and population-specific height standards in the absence of growth hormone (GH) deficiency or other known etiologies. ISS is a registered indication for GH therapy in USA but not in Europe. The psychosocial burden of ISS remains underexplored, including its impact on quality of life. Using National...

hrp0098p1-58 | GH and IGFs 1 | ESPE2024

Somapacitan is Effective and Well Tolerated in Chinese Children with GHD: 52-week Results from the Randomized Phase 3 REAL6 Trial

Fu Junfen , Cheng Xinran , Højby Michael , Gong Chunxiu , Lund Leunbach Tina , Li Yanhong , Wei Haiyan , Zhu Yu , Zhang Yining , Zhong Yan

Somapacitan is currently the only long-acting GH approved by FDA, PDMA and EMA to treat GH deficiency (GHD) in both children and adults. Similar efficacy, safety, and tolerability in children with GHD was demonstrated for somapacitan (0.16 mg/kg/week) compared to daily GH (0.034 mg/kg/day) in the global phase 3 REAL4 study, which was conducted in 20 countries within Asia (excluding China), Europe, and North America. Efficacy and safety of somapacitan in Chinese children with G...