Novo has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for once-weekly Sogroya to treat children with idiopathic short stature (ISS) and persistent growth disturbance.

 

If approved by the European Commission, Sogroya would become the first and only growth hormone treatment authorised for ISS in the European Union, potentially giving children and families affected by the condition a new treatment option.

 

“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 but remains under-recognised, with treatment options varying significantly between countries. The condition is diagnosed when a child is significantly shorter than peers and no underlying medical cause can be identified.

 

The CHMP recommendation is based on data from the REAL8 clinical trial, which evaluated once-weekly Sogroya against once-daily growth hormone treatment in children with ISS, as well as children born small for gestational age (SGA) and those with Noonan Syndrome (NS).

 

The treatment is a long-acting growth hormone analogue administered as a single injection under the skin once a week.

 

“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.

 

The latest recommendation follows the CHMP’s recommendation in May 2026 for Sogroya to treat short stature in children born SGA and children with Noonan Syndrome.

 

The recommendation now goes to the European Commission, which is expected to make a decision on marketing authorisation covering all three indications later this year.

 

Data from the REAL8 trial 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 ISS, SGA and Noonan Syndrome.

 

Sogroya uses albumin-binding technology, allowing the growth hormone analogue to attach to a protein naturally present in the blood and remain in the body for longer.