Novo Nordisk has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending once-weekly Sogroya, or somapacitan, for children in Europe living with idiopathic short stature with persistent growth disturbance. If approved, Sogroya would be the first and only growth hormone treatment approved for idiopathic short stature in the EU, a condition that affects up to 3% of children worldwide. The opinion follows the CHMP's May 2026 recommendation of Sogroya for short stature in children born small for gestational age and with Noonan Syndrome, and the decision now passes to the European Commission, whose ruling on marketing authorisation covering all three indications is expected later this year. The recommendation was supported by data from the REAL8 phase 3 basket trial, in which once-weekly Sogroya was non-inferior to once-daily growth hormone treatment for mean annualised height velocity at Week 52 in children with idiopathic short stature, those born small for gestational age and those with Noonan Syndrome. Sogroya is already authorised in the EU for growth hormone deficiency in adults since 31 March 2021 and in children aged 3 years and older since 24 July 2023.
Novo Nordisk A/SCHMP positive opinion recommends once-weekly Sogroya for idiopathic short stature in children, advancing EU marketing authorization.
