Novo Nordisk's Sogroya wins CHMP backing for idiopathic short stature

Novo Nordisk has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), recommending its once-weekly somapacitan (Sogroya) for children with idiopathic short stature (ISS) accompanied by persistent growth disturbance. If the European Commission grants marketing authorisation, as expected later this year, Sogroya would become the first growth hormone therapy approved specifically for ISS in the EU.

ISS is defined as significant short stature in children for whom no underlying medical cause can be identified. It affects an estimated 3% of children worldwide and is associated with elevated risks of bullying, social exclusion, and diminished self-confidence. Despite its prevalence, it remains unrecognised as a formal condition in many countries, and access to growth hormone therapy for ISS is inconsistent across Europe, with treatment often used off-label or withheld entirely.

Trial data and mechanism

The CHMP recommendation rests on data from the REAL8 Phase 3 basket study, which assessed Sogroya across three paediatric indications: ISS, small for gestational age, and Noonan Syndrome. Results showed that once-weekly somapacitan was non-inferior to once-daily growth hormone treatment for mean annualised height velocity at 52 weeks in children with ISS. The drug works through albumin-binding technology, enabling a single subcutaneous injection per week rather than the daily injections required by conventional recombinant growth hormone formulations.

The dosing convenience is clinically meaningful. Adherence to daily injection regimens in paediatric patients can be poor, and a weekly formulation reduces both the injection burden on children and the logistical demands on families. Martin Holst Lange, executive vice president and chief scientific officer at Novo Nordisk, described the CHMP recommendation as "a very important step forward for children and their families affected by ISS across Europe."

Regulatory path and market context

Today's opinion follows a CHMP recommendation issued in May 2026 for Sogroya in small for gestational age and Noonan Syndrome, meaning the European Commission will now rule on a marketing authorisation covering all three paediatric indications in a single decision. Sogroya already holds EU approval for growth hormone deficiency in adults (2021) and in children aged three and over (2023), giving Novo Nordisk a well-established regulatory dossier for the product.

The ISS indication is commercially distinct because it represents a sizeable, underserved population that is currently outside the approved treatment framework in Europe. In the United States, growth hormone therapy for ISS has been approved by the FDA since 2003, with a handful of products on label, but EU approval has historically been withheld on the grounds that evidence of meaningful height gain relative to placebo was insufficiently robust to justify treatment in an otherwise healthy population. The REAL8 non-inferiority data shifts that argument: regulators can now assess Sogroya against an active comparator rather than relying solely on placebo-controlled height-gain data.

Competition in the long-acting growth hormone space is intensifying. Pfizer and OPKO Health market Ngenla (somatrogon), another once-weekly growth hormone analogue, which received EU approval for paediatric growth hormone deficiency in 2021. Neither Ngenla nor any competing long-acting product currently holds an EU ISS indication, so Novo Nordisk would, if approved, hold a meaningful first-mover position in this sub-category. How quickly national health technology assessment bodies across EU member states are willing to reimburse Sogroya for ISS, given the condition's contested clinical status in some markets, will be the key commercial variable to watch in 2027.