Novo's Sogroya Gains CHMP Nod for Idiopathic Short Stature in the EU

Novo NVO 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) for treating children with idiopathic short stature (ISS) and persistent growth disturbance. The non-binding recommendation will now be reviewed by the European Commission to make a final decision. If approved, Sogroya would become the first and only growth hormone treatment approved for ISS in the EU, potentially expanding Novo's presence in the pediatric growth disorder market.