Novo Nordisk Sogroya Gains Positive CHMP Opinion in Europe

Bagsværd, Denmark, September 18, 2026

Novo Nordisk Advances Weekly Sogroya for Children

The positive CHMP opinion recommends Sogroya (somapacitan) for children in Europe living with idiopathic short stature and persistent growth disturbance. ISS is diagnosed when a child is significantly shorter than peers and no underlying medical cause can be identified after appropriate evaluation. Novo Nordisk estimates that ISS affects up to 3% of children worldwide, although recognition and treatment approaches vary between countries. Sogroya is a long-acting human growth hormone analogue administered through a single subcutaneous injection once a week. The medicine uses albumin-binding technology, which enables somapacitan to bind to albumin, a naturally occurring protein in the blood, and remain in circulation for a longer period. This pharmacological design allows weekly rather than daily administration.

In the European Union, Sogroya is already authorised for growth hormone deficiency in adults and for children aged three years and older. The latest CHMP recommendation would expand its potential pediatric use to children with idiopathic short stature and persistent growth disturbance. The recommendation is particularly relevant because treatment with growth hormone for ISS is not uniformly approved across different countries. The regulatory pathway in Europe could therefore establish a new authorised treatment option for children meeting the specified criteria.

REAL8 Trial Supports Sogroya Growth Outcomes

The positive CHMP opinion is supported by data from the REAL8 Phase 3 clinical trial, which evaluated once-weekly Sogroya in children with growth disorders, including idiopathic short stature, children born small for gestational age, and children with Noonan syndrome. According to Novo Nordisk, the trial demonstrated that once-weekly Sogroya was non-inferior to once-daily growth hormone treatment for mean annualised height velocity at Week 52. Annualised height velocity is an important measure in pediatric growth studies because it assesses the rate at which a child grows over a specified period. The REAL8 findings provided the clinical evidence supporting the company’s regulatory submission for the additional pediatric indications.

The CHMP recommendation follows an earlier regulatory milestone for Sogroya. In May 2026, the committee recommended Sogroya for short stature in children born small for gestational age (SGA) and children with Noonan syndrome (NS). The latest opinion therefore potentially expands the number of pediatric growth conditions for which Sogroya could be authorised in Europe. While the clinical results support the regulatory recommendation, the CHMP opinion is not yet the final European marketing authorisation. The recommendation has now been forwarded to the European Commission, which is expected to make the final decision on marketing authorisation covering the three pediatric indications later in 2026.

Novo Nordisk Expands Pediatric Growth Hormone Options

Idiopathic short stature can be challenging to diagnose because it is defined only after other potential causes of short stature have been excluded. Children with ISS may also experience psychosocial challenges associated with being substantially shorter than their peers. Novo Nordisk cited research indicating that the condition can affect confidence and wellbeing, while diagnosis may sometimes occur relatively late in childhood. If the European Commission confirms the CHMP recommendation, Sogroya would become the first and only growth hormone treatment approved for ISS in the EU, according to Novo Nordisk. The decision would add to the company’s established portfolio of growth hormone therapies and further expand the potential use of once-weekly somapacitan in pediatric endocrinology.

The development also reflects the pharmaceutical industry’s continuing efforts to develop long-acting growth hormone treatments that can reduce the frequency of injections while maintaining therapeutic growth hormone exposure. Sogroya’s weekly administration distinguishes it from traditional daily growth hormone therapy and may offer an alternative dosing schedule for eligible patients. For Novo Nordisk, the positive CHMP opinion represents another regulatory milestone for Sogroya in pediatric growth disorders. The final European Commission decision will determine whether the recommended indication receives marketing authorisation. Until that decision, the CHMP opinion should be considered a regulatory recommendation rather than a final approval.

Source: Novo Nordisk press release