Novo Nordisk's once-weekly growth hormone therapy Sogroya, also known as somapacitan, received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for treating children with idiopathic short stature and persistent growth disturbance. The non-binding recommendation now goes to the European Commission for a final decision, and if approved Sogroya would become the first and only growth hormone treatment cleared for idiopathic short stature in the EU. The recommendation was supported by data from Novo's phase III REAL8 basket study, which evaluated once-weekly Sogroya in children with idiopathic short stature as well as those born small for gestational age and children with Noonan Syndrome, showing the drug was non-inferior to once-daily growth hormone treatment in mean annualized height velocity at week 52. The CHMP opinion follows a similar recommendation issued in May 2026 for Sogroya in children with short stature associated with being born small for gestational age and with Noonan Syndrome, and a European Commission decision covering all three indications is expected later this year. Sogroya is already authorized in the EU for growth hormone deficiency in adults and children aged three years and older, and its U.S. label was expanded in 2026 to include children with short stature associated with being born small for gestational age, Noonan Syndrome and idiopathic short stature. Idiopathic short stature affects up to 3% of children worldwide, and year to date NVO shares have lost 15% against the industry's 12.3% growth.
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Aldeyra TheNovo Nordisk A/SCHMP positive opinion for Sogroya in idiopathic short stature advances EU approval, potentially making it the first and only such treatment in the EU
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