The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended three new pediatric indications for Sogroya (somapacitan; Novo Nordisk), covering idiopathic short stature (ISS), short children born small for gestational age who have failed to show catch-up growth, and Noonan syndrome. 

If approved by the European Commission, Sogroya would become the first and only growth hormone therapy authorized for ISS in the EU.

ISS is diagnosed in children who are markedly shorter than their peers with no identifiable underlying cause; it is estimated to affect up to 3% of children worldwide. Because it can only be diagnosed after other causes of short stature are excluded, children are often not identified until later in childhood, narrowing the window for effective growth hormone (GH) intervention, and treatment access has historically been inconsistent across the EU, with GH used off-label or not at all in ISS in many countries.

Mechanism of Action 

Somapacitan is a long-acting recombinant human GH analogue engineered with a reversible albumin-binding moiety. By noncovalently attaching to circulating albumin, the molecule is protected from rapid clearance, extending its half-life enough to allow once-weekly subcutaneous dosing in place of the daily injections required with conventional recombinant GH.

Clinical Evidence 

Supporting evidence included data from the phase 3 REAL8 basket trial, which evaluated once-weekly somapacitan in children with idiopathic short stature, children born small for gestational age, and children with Noonan syndrome. In the ISS setting, once-weekly somapacitan was noninferior to daily growth hormone on annualized height velocity at 52 weeks.

The positive opinion followed re-examination of an initial CHMP opinion issued in May 2026. Sogroya was first approved in the EU for adult growth hormone deficiency in March 2021, followed by approval in children aged 3 years or older with pediatric growth hormone deficiency in July 2023.

Next Steps 

The positive opinion for Sogroya now goes to the European Commission, which typically finalizes marketing authorization decisions within about 67 days of a CHMP recommendation. Detailed recommendations for the use of this product will be provided in the updated Summary of Product Characteristics, which will be published on the EMA website in all official European Union languages upon final approval. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.