Novo Nordisk (NVO) said Friday the European Medicines Agency's CHMP recommended once-weekly Sogroya for children with idiopathic short stature and persistent growth disturbance.
If approved by the European Commission, Sogroya would become the first and only growth hormone treatment approved for idiopathic short stature in the EU, the company said.
The recommendation follows earlier CHMP support for Sogroya in children born small for gestational age and those with Noonan syndrome, it added.
The European Commission's decision on marketing authorization covering all three indications is expected later this year, Novo Nordisk said.