ANDRIEVSKII.CH | Novo Nordisk A/S (NOVO-B.CO): SOGROYA SET FOR POTENTIAL EXPANSION IN EUROPE

Bagsværd, Denmark, Sept. 18, 2026 — Novo Nordisk said the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending once-weekly Sogroya (somapacitan) for 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 approved for ISS in the EU, potentially expanding Novo Nordisk’s pediatric growth-hormone franchise. The Commission’s decision is expected later this year.

ISS describes children who are significantly shorter than their peers when no underlying medical cause can be identified. According to Novo Nordisk, the condition affects up to 3% of children worldwide, while treatment options remain limited.

The positive opinion is based on data from the REAL8 clinical trial, which showed that once-weekly Sogroya was non-inferior to daily growth-hormone treatment for mean annualized height velocity at Week 52 in children with ISS, as well as in children born small for gestational age (SGA) and those with Noonan syndrome.

Sogroya is a long-acting human growth-hormone analogue administered by a single subcutaneous injection once a week. Its albumin-binding technology allows the medicine to remain in the body for longer.

The September opinion follows the May 2026 positive CHMP opinion covering children born SGA and those with Noonan syndrome. That opinion subsequently became subject to a re-examination procedure. The European Commission will make the final regulatory decision.

In the EU, Sogroya is already authorised for growth-hormone deficiency in adults and children aged three and older.

Andrievskii Verdict

The potential expansion strengthens Sogroya’s position within Novo Nordisk’s growth-hormone franchise and could broaden its addressable pediatric market. The next regulatory catalyst is the European Commission’s final decision, followed by reimbursement and market-access decisions across individual EU countries.

Aleksei Andrievskii | Advisory Board Member, Bendura Bank AG | Liechtenstein