CHMP of the European Medicines Agency Recommends Approving Novo Nordisk's Once-Weekly Sogroya for Children with Idiopathic Short Stature with Persistent Growth Disturbance

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended once-weekly Sogroya® (somapacitan) for children in Europe living with idiopathic short stature (ISS) with persistent growth disturbance.ISS is a diagnosis given to children who are significantly shorter than their peers when no underlying medical cause can be found, affecting a child's confidence and well-being1-4. This affects up to 3% of children worldwide1,6,8.Positive opinion follows the previous recommendation for Sogroya® in the treatment of short stature in children born Small for Gestational Age (SGA) and with Noonan Syndrome (NS) in Europe5.Bagsværd, Denmark, 18 September 2026 – Novo Nordisk today welcomed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending once-weekly Sogroya® for children with idiopathic short stature (ISS) with persistent growth disturbance."Through our research and relationships with the community, we know that 70% of families raising children with ISS and other growth disorders feel unseen, and that the impact on their child's daily life simply isn't recognised," said Ashley Gilmer, chief executive officer of International Coalition of Organizations Supporting Endocrine Patients (ICOSEP). "This recommendation is a meaningful signal that this may be starting to change. What matters now is that recognition turns into real support of timely diagnosis, clear information, and access to care for every family who needs it."ISS affects up to 3% of children worldwide, yet it remains under-recognised and has limited options for managing its treatment1,6-8. As part of the REAL8 clinical trial, Sogroya® has been assessed for the treatment of ISS and acts as a long-acting growth hormone, given as a single injection under the skin once a week9,10. If approved, Sogroya® would be the first and only growth hormone treatment approved for ISS in the EU, providing a much-needed treatment option for children and their families living with this condition."For too long, treatment options for many children with growth disorders have been limited. Building on our decades of experience in growth hormone medicines, we’re committed to changing that. Today’s approval recommendation from the CHMP is a very important step forward for children and their families affected by ISS across Europe," said Martin Holst Lange, executive vice president, chief scientific officer and head of Research & Development at Novo.This opinion follows the CHMP recommendation of Sogroya® for the treatment of short stature in children born small for gestational age (SGA) and Noonan Syndrome (NS) in May 20265. The opinion is now passed to the European Commission, whose decision on marketing authorisation, covering all three indications, is expected later this year.About once-weekly Sogroya® (somapacitan)Once-weekly Sogroya® (somapacitan) is a long-acting human growth hormone analogue, given as a single injection under the skin once a week. It uses albumin-binding technology, which allows the growth hormone to attach to a protein naturally present in the blood, allowing it to remain in the body for longer11.In the EU, Sogroya® was authorised for the treatment of growth hormone deficiency in adults on 31 March 2021 and in children aged 3 years and older on 24 July 2023.The REAL8 clinical trial data that supported this positive CHMP opinion showed that once-weekly Sogroya® was non-inferior to once-daily growth hormone treatment for mean annualised height velocity at Week 52 in children with idiopathic short stature, born small for gestational age and Noonan Syndrome9.