Novo Nordisk gains EU Sogroya recommendation

• Novo Nordisk (NYSE:NVO) received a positive CHMP opinion for once-weekly Sogroya in children with idiopathic short stature.
• The recommendation could expand Sogroya’s use across additional pediatric growth conditions in Europe.
• The European Commission will make the final marketing authorization decision later in 2026.

Novo Nordisk (NYSE:NVO) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending once-weekly Sogroya (somapacitan) for children in Europe with idiopathic short stature and persistent growth disturbance.

The recommendation follows Phase 3 REAL8 trial results, where once-weekly Sogroya was shown to be non-inferior to once-daily growth hormone treatment for mean annualised height velocity at Week 52 in children with idiopathic short stature, small for gestational age and Noonan Syndrome.

If approved by the European Commission, Sogroya would become the first and only growth hormone treatment authorised for idiopathic short stature in the European Union, while the decision would also cover the small for gestational age and Noonan Syndrome indications.

Novo Nordisk develops medicines across areas including diabetes, obesity, rare diseases and hormone-related conditions, with Sogroya currently approved in the European Union for growth hormone deficiency in adults and children aged three years and older.

The European Commission is expected to issue a marketing authorization decision covering the three pediatric indications later in 2026, following review of the CHMP recommendation.