Novo Nordisk Gets Positive EU Opinion for Sogroya in Short Stature

Novo Nordisk has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) for the use of Sogroya in children with idiopathic short stature (ISS) and persistent growth problems.

The recommendation from the European Medicines Agency (EMA) committee could open the way for Sogroya to become a new treatment option for children with ISS in the European Union.

Idiopathic short stature affects up to 3% of children worldwide, but the condition remains under-recognised and treatment options are limited. Children with ISS are shorter than expected for their age and sex, without another identified medical cause explaining the growth pattern.

Sogroya is a long-acting growth hormone treatment administered as a once-weekly injection under the skin. Novo Nordisk evaluated the treatment for ISS in the REAL8 clinical trial.

If approved by the European Commission, Sogroya would be the first and only growth hormone treatment approved specifically for ISS in the EU, according to Novo Nordisk.

Ashley Gilmer, chief executive officer of the International Coalition of Organizations Supporting Endocrine Patients (ICOSEP), said many families affected by ISS feel that the condition and its impact on children’s daily lives are not sufficiently recognised. She said the recommendation could represent progress toward better diagnosis, information and access to care.

Martin Holst Lange, executive vice president, chief scientific officer and head of Research & Development at Novo Nordisk, said the company has been working to expand treatment options for children with growth disorders.

The latest CHMP opinion follows recommendations issued in May 2026 for Sogroya to treat short stature in children born small for gestational age (SGA) and children with Noonan syndrome (NS).

The recommendation will now be reviewed by the European Commission. A decision on marketing authorisation covering the three indications is expected later this year.

If the European Commission grants approval, the decision could expand the use of Sogroya in children with different growth disorders across Europe.