The Novo’s Sogroya CHMP opinion marks a major regulatory milestone for pediatric endocrinology as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended once-weekly Sogroya® (somapacitan) for children in Europe living with idiopathic short stature (ISS) accompanied by persistent growth disturbance. Announced on September 18, 2026, from Bagsværd, Denmark, this positive opinion sets the stage for European Commission marketing authorization. If approved, Sogroya® will become the first and only human growth hormone treatment authorized for idiopathic short stature in the European Union, offering a long-acting weekly option for affected children and their families.
Idiopathic short stature is a clinical diagnosis designated for children who are significantly shorter than their peers when no underlying medical etiology can be identified. The condition affects up to 3% of children worldwide, yet remains widely under-recognized and unaddressed in many regions. Research cited by Novo indicates that nearly 70% of families raising children with ISS and other growth disorders report feeling unseen, with the profound daily impact on childhood confidence, well-being, and social interaction frequently overlooked. Because diagnosis requires ruling out all other causes of short stature, children are often not evaluated until close to puberty, leaving a narrow time window for effective therapeutic intervention.
Sogroya® (somapacitan) is a long-acting human growth hormone analogue designed for subcutaneous injection once per week. It utilizes an advanced albumin-binding technology that enables somapacitan to reversibly bind to endogenous serum albumin in the bloodstream, slowing its clearance and extending its therapeutic action in the body. The recommended weekly regimen is intended to offer a significant convenience advantage over standard once-daily growth hormone administration, easing the emotional and treatment burden on pediatric patients.
Clinical Data Supporting the Novo’s Sogroya CHMP Opinion
The positive recommendation from the CHMP is primarily supported by results from the REAL8 Phase 3 clinical trial. In this study, once-weekly Sogroya® demonstrated non-inferiority to conventional once-daily growth hormone treatment as measured by mean annualized height velocity at Week 52 in children diagnosed with idiopathic short stature, children born small for gestational age (SGA), and those with Noonan Syndrome (NS). The trial results confirmed that somapacitan is effective and well-tolerated in pediatric populations across multiple growth failure etiologies.
This latest regulatory recommendation builds upon earlier EMA milestones for somapacitan in Europe. In May 2026, the CHMP recommended Sogroya® for the treatment of short stature in children born small for gestational age and children with Noonan Syndrome. Prior to expanding into pediatric growth disorders, Sogroya® received EMA authorization for adult growth hormone deficiency on March 31, 2021, followed by pediatric authorization for growth hormone deficiency in children aged 3 years and older on July 24, 2023. The pending European Commission decision will unify marketing authorization across all three pediatric growth disturbance indications: ISS, SGA, and Noonan Syndrome.
Commenting on the positive recommendation, Martin Holst Lange, Executive Vice President, Chief Scientific Officer and Head of Research & Development at Novo, stated that building on decades of experience in growth hormone therapies, the company remains dedicated to expanding options for children whose growth disorders have long had limited therapeutic solutions. Ashley Gilmer, Chief Executive Officer of the International Coalition of Organizations Supporting Endocrine Patients (ICOSEP), noted that the recommendation represents a critical step toward turning recognition into tangible support, timely diagnosis, and access to care for families affected by ISS. The CHMP’s positive opinion has now been referred to the European Commission, with a final decision on marketing authorization across all EU member states expected later in 2026.
