Europe Moves Toward Growth Hormone for Short Stature in Children

CHMP Positive Opinion for Sogroya in Idiopathic Short Stature

Novo Nordisk said the European Union's drug regulator recommended the approval of its Sogroya growth-hormone treatment for children with unexplained shortness, expanding the medicine's current label. The Danish drugmaker said Friday that the European Medicines Agency's human-drugs committee issued a positive opinion on its Sogroya injection for children with idiopathic short stature.

If approved, Sogroya (somapacitan) would be the first and only growth hormone treatment approved for idiopathic short stature in the EU, providing a much-needed treatment option for children and their families affected by this condition.

What Idiopathic Short Stature Means

Idiopathic short stature affects children who remain significantly shorter than peers without an identifiable underlying medical cause. It is defined as height >2 standard deviations below mean for age and sex, without growth hormone deficiency, Turner syndrome, or other systemic disease. In the US, growth hormone has been approved for ISS since 2003, but EU had no approval until now.

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 child's daily life is significant, Novo noted.

Once-Weekly Advantage Over Daily Shots

Bagsværd, Denmark, 18 September 2026 – Novo Nordisk welcomed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending once-weekly Sogroya for children with idiopathic short stature with persistent growth disturbance.

Sogroya is somapacitan, a long-acting human growth hormone derivative with albumin-binding technology allowing weekly dosing. Current standard for ISS in US requires daily injections for years, leading to adherence issues. Weekly option could transform acceptance.

REAL8 Trial Basis

The CHMP recommendation is based on data from the REAL8 clinical trial. Announced on September 18, 2026, from Bagsværd, Denmark, this positive opinion sets the stage for European Commission marketing authorization. REAL8 evaluated growth velocity and height SDS improvement in children with ISS treated with weekly somapacitan versus daily Norditropin or no treatment, showing non-inferior annualized height velocity.

If approved by the European Commission, Sogroya would become the first and only growth hormone treatment approved for idiopathic short stature in the European Union.

What Changes for European Families

Novo gets EU regulator backing to expand label of growth-hormone treatment. The European Commission will now review the recommendation, with final decision expected in Q4 2026. If granted, families across EU27 would gain reimbursed access where previously growth hormone for ISS was off-label and rarely paid.

The recommendation could expand Sogroya's reach across Europe, as Sogroya secures key CHMP recommendation. Novo Nordisk A/S stock surged on news as investors see ISS as large prevalent population versus rare GH deficiency.

Ethical and Clinical Debate

Europe has historically been more conservative about growth hormone for non-deficiency short stature due to concerns about medicalizing shortness, long-term safety, and cost-effectiveness. CHMP opinion signals shift toward recognizing psychosocial burden of severe short stature. Strict criteria will apply: persistent growth disturbance, exclusion of other causes, and predicted adult height significantly below target.

Next Steps and Global Context

Novo's once-weekly Sogroya receives positive CHMP opinion in Europe for children with idiopathic short stature (unexplained shortness). If Commission approves, launch in early 2027 with growth disorder center training. In US, Sogroya is approved for GH deficiency but ISS filing is pending, making EU first to approve weekly GH for ISS.

This positions Novo against Pfizer's Ngenla (somatrogon) weekly, which is not approved for ISS in EU, giving Sogroya first-mover advantage in this controversial but large indication.

Working Source Links:

Novo Gets EU Regulator Backing to Expand Label of Growth-Hormone Treatment - Morningstar - https://www.morningstar.com/news/dow-jones/202609182667/novo-gets-eu-regulator-backing-to-expand-label-of-growth-hormone-treatment

Novo's once-weekly Sogroya receives positive CHMP opinion for idiopathic short stature - GlobeNewswire - https://www.globenewswire.com/news-release/2026/09/18/3364591/0/en/novos-once-weekly-sogroya-somapacitan-receives-positive-chmp-opinion-in-europe-for-children-with-idiopathic-short-stature-unexplained-shortness.html

Novo Sogroya CHMP Opinion: EMA Recommends Once-Weekly Somapacitan for Idiopathic Short Stature - https://www.biotechreality.com/2026/09/ novo-sogroya-chmp-opinion.html

Novo Nordisk Sogroya Gains Positive CHMP Opinion in Europe - https://cgxpwire.com/novo-nordisk-sogroya-gains-positive-chmp-opinion-in-europe/

Novo gets positive EU recommendation for weekly growth hormone treatment in children with short stature - https://www.indianpharmapost.com/search/CHMP/page-6