EMA Committee Backs Sogroya for Idiopathic Short Stature in Children
核心洞察
The EMA's CHMP issued a positive opinion recommending once-weekly Sogroya (somapacitan) for children with idiopathic short stature (搜索) and persistent growth disturbance.
If approved, Sogroya would become the first and only growth hormone treatment authorised for idiopathic short stature (搜索) in the European Union.
The recommendation rests on the REAL8 trial, in which once-weekly Sogroya was non-inferior to once-daily growth hormone for mean annualised height velocity at Week 52.
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (搜索) (CHMP) has recommended approval of once-weekly Sogroya (somapacitan) for children with idiopathic short stature (搜索) (ISS) and persistent growth disturbance, Novo Nordisk said. The positive opinion, issued Friday, would expand the medicine's existing European label.
If the European Commission grants marketing authorisation, Sogroya could become the first and only growth hormone treatment approved for ISS in the European Union.
Condition and Unmet Need
ISS is a condition in which children are significantly shorter than their peers without an identifiable underlying medical cause. According to Novo Nordisk, the condition affects up to 3% of children worldwide. No growth hormone therapy is currently authorised for this indication in the EU.
REAL8 Trial Supports the Filing
The CHMP recommendation was supported by data from the REAL8 clinical trial, which evaluated once-weekly Sogroya in children with ISS as well as in children born small for gestational age (SGA) and those with Noonan Syndrome (搜索). In the study, once-weekly Sogroya was non-inferior to once-daily growth hormone treatment for mean annualised height velocity at Week 52.
Sogroya is a long-acting human growth hormone analogue given as a single subcutaneous injection once a week. The medicine uses albumin binding, which allows it to remain in the body for longer.
Regulatory Path Across Three Indications
The ISS opinion follows the CHMP's May 2026 positive opinion for Sogroya in children with short stature who were born SGA and children with Noonan Syndrome (搜索). Novo Nordisk said it expects the European Commission, the EU's executive arm, to decide on approval covering all three indications later this year.
Sogroya is already authorised in the EU for growth hormone deficiency (搜索) in adults and in children aged 3 years and older.
Novo Nordisk is focused on developing and commercialising medicines for growth disorders, obesity, diabetes and other serious chronic diseases.