Novo Nordisk’s Sogroya recommended by EMA CHMP for idiopathic short stature in children

CHMP recommendation

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending once‑weekly Sogroya (somapacitan) for children in Europe with idiopathic short stature (ISS) and persistent growth disturbance. If authorised, it would be the first growth hormone treatment approved for ISS in the EU.

Clinical evidence

Support comes from the REAL8 phase‑3 basket trial, which showed once‑weekly somapacitan was non‑inferior to once‑daily growth hormone for mean annualised height velocity at Week 52 in children with ISS, and in cohorts born small for gestational age (SGA) and with Noonan Syndrome (NS).

Regulatory path

The CHMP opinion follows an earlier May 2026 recommendation for Sogroya in SGA and NS. The opinion has been forwarded to the European Commission, whose decision on marketing authorisation covering all three indications is expected later this year.

Condition context

Idiopathic short stature is diagnosed when a child is significantly shorter than peers with no identifiable medical cause; it affects up to 3% of children worldwide, is often under‑recognised, and can be linked to psychosocial harm. Sogroya is a long‑acting human growth hormone analogue that uses albumin‑binding technology to extend circulating time and is already authorised in the EU for adult growth hormone deficiency (2021) and for children aged 3 and older (2023).