Novo Nordisk's Sogroya wins EU backing for short stature

Novo Nordisk announced that its once-weekly growth hormone therapy Sogroya (somapacitan) received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The recommendation covers the treatment of children with idiopathic short stature (ISS) and persistent growth disturbance.

The European Commission will review the non-binding opinion to issue a final decision later this year. If cleared, Sogroya would become the first and only growth hormone therapy approved for ISS in the European Union. The condition affects up to 3% of children worldwide without an identifiable underlying medical cause.

The CHMP opinion was supported by data from the phase III REAL8 basket trial, which evaluated once-weekly Sogroya in children with ISS, those born small for gestational age (SGA), and patients with Noonan Syndrome (NS). At week 52, Sogroya was non-inferior to once-daily growth hormone treatment in mean annualized height velocity. The endorsement follows a May 2026 CHMP recommendation for SGA and NS.

Sogroya is already approved in the EU for growth hormone deficiency in adults and children aged three years and older, as well as in the United States, Japan, and China. Its US label expanded in 2026 to include SGA, NS, and ISS. Year to date, Novo Nordisk shares have lost 15% against a 12.3% gain for its industry.