Novo Nordisk’s once-weekly Sogroya receives positive CHMP opinion in Europe for children with idiopathic short stature

If approved, Sogroya® would become the first and only growth hormone treatment cleared for idiopathic short stature in the EU, offering a long-awaited treatment option for children and families affected by the condition.

The Committee for Medicinal Products for Human Use at the European Medicines Agency has recommended once-weekly Sogroya® for children in Europe living with idiopathic short stature accompanied by persistent growth disturbance. The diagnosis is given to children who are significantly shorter than their peers with no identifiable underlying medical cause, a condition that can affect a child’s confidence and overall wellbeing and impacts up to 3 percent of children worldwide. This positive opinion follows an earlier recommendation for Sogroya® in treating short stature among children born small for gestational age and those with Noonan syndrome in Europe.

Novo Nordisk welcomed the positive opinion from the CHMP, which recommends once-weekly Sogroya® for children with idiopathic short stature accompanied by persistent growth disturbance.

Ashley Gilmer, chief executive officer of the International Coalition of Organizations Supporting Endocrine Patients, said research and engagement with the community show that 70 percent of families raising children with idiopathic short stature and other growth disorders feel unseen, with the impact on their child’s daily life often going unrecognized. She said this recommendation sends a meaningful signal that the situation may be starting to shift, and that what matters now is turning that recognition into real support through timely diagnosis, clear information, and access to care for every family who needs it.

Idiopathic short stature affects up to 3 percent of children worldwide, yet remains under-recognized and offers limited treatment options. As part of the REAL8 clinical trial, Sogroya® was evaluated as a treatment for the condition, functioning as a long-acting growth hormone delivered through a single injection under the skin once a week. If approved, it would become the first and only growth hormone treatment authorized for idiopathic short stature in the EU, filling a significant gap for children and families managing the condition.

Martin Holst Lange, executive vice president, chief scientific officer, and head of research and development at Novo Nordisk, said treatment options for many children with growth disorders have remained limited for far too long. He said that building on decades of experience in growth hormone medicines, the company is committed to changing that, and described the CHMP’s recommendation as an important step forward for children and families affected by idiopathic short stature across Europe.

This opinion follows the CHMP’s recommendation in May 2026 to approve Sogroya® for treating short stature in children born small for gestational age and those with Noonan syndrome. The opinion now moves to the European Commission, whose decision on marketing authorization, covering all three indications, is expected later this year.

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Related Topics and Keywords

idiopathic short stature, Novo Nordisk, Positive CHMP Opinion, sogroya, Sogroya® (somapacitan)