On Feb. 27, 2026, Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved three new indications for once-weekly Sogroya^® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg, a long-acting growth hormone. Sogroya^® is now indicated for children aged 2.5 years and older with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS). Sogroya^® is also indicated for children aged 2.5 years and older and adults with growth hormone deficiency (GHD).

REAL8, the pivotal study for these approvals, contained three sub studies that achieved their primary endpoint, demonstrating that once-weekly Sogroya^® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg was non-inferior to once-daily growth hormone treatment for mean annualized height velocity (AHV) at Week 52 across these three indications in children aged 2.5 years and older:

• In children with ISS, Sogroya^® demonstrated non-inferiority in mean AHV compared with daily somatropin (10.2 vs 10.5 cm/year). The dose of 0.05 mg/kg/day of daily somatropin is less than maximum dose approved dose (0.067 mg/kg/day) for use in pediatric patients in the US.
• In children born SGA with no catch up by 2 years of age, Sogroya^® demonstrated non-inferiority compared to both daily growth hormone doses (0.035 mg/kg/day and 0.067 mg/kg/day) with a mean AHV of 11.0 cm/year vs 9.4 cm/year vs 11.1 cm year respectively; daily growth hormone dose of 0.035 mg/kg/day is less than the maximum approved dose (0.067 mg/kg/day) in the US.
• In children with growth failure associated with NS, Sogroya^® demonstrated non-inferiority in mean AHV compared to daily somatropin (10.4 vs 9.2 cm/year); the daily somatropin dose of 0.050 mg/kg/day used is less than the maximum approved dose (0.066 mg/kg/day) in the US.

In REAL8, the adverse reactions occurring in ≥10% of patients treated with Sogroya^® across all three indications were respiratory tract infection, nasopharyngitis, ear infection, and diarrhea. Additional reactions occurring in ≥10% of patients treated with Sogroya^® included: headache in ISS and NS; cough, pyrexia, and vomiting in NS and SGA; and injection site reaction in ISS.