Novo Nordisk Receives Positive Opinion for Sogroya® in Europe

Bagsværd, Denmark, 18 September 2026, Novo Nordisk has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the use of Sogroya® (somapacitan) for children with idiopathic short stature (ISS) with persistent growth disturbance. This 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 Europe.

Idiopathic short stature is a diagnosis given to children who are significantly shorter than their peers when no underlying medical cause can be found. This condition affects up to 3% of children worldwide, yet it remains under-recognized and has limited treatment options. The positive opinion from the CHMP is a significant step forward for children and their families affected by ISS, as Sogroya® would be the first and only growth hormone treatment approved for ISS in the EU.

Sogroya® is a long-acting 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 remain in the body for longer, providing a more convenient treatment option for children. The REAL8 clinical trial data that supported this positive CHMP opinion showed that Sogroya® was non-inferior to once-daily growth hormone treatment for mean annualized height velocity at Week 52 in children with ISS.

According to Ashley Gilmer, CEO of the International Coalition of Organizations Supporting Endocrine Patients (ICOSEP), 70% of families raising children with ISS and other growth disorders feel unseen, and the impact on their child's daily life is not recognized.

The positive opinion from the CHMP is now passed to the European Commission, whose decision on marketing authorization, covering all three indications, is expected later this year. If approved, Sogroya® would provide a much-needed treatment option for children and their families living with ISS, addressing the limited options available for managing the condition.

In the EU, Sogroya® was previously authorized 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 positive opinion from the CHMP is a significant milestone in the ongoing efforts to improve the lives of children with ISS and other growth disorders.