EMA panel backs Novo Nordisk's Sogroya for children's growth disorder

Novo Nordisk (NYSE: NVO) said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending once-weekly Sogroya for children with idiopathic short stature (ISS) with persistent growth disturbance.

ISS affects up to 3% of children worldwide. If the European Commission grants marketing authorization, Sogroya would be the first growth hormone treatment approved for ISS in the European Union, according to the company.

Sogroya is a long-acting growth hormone administered as a single subcutaneous injection once a week. It was evaluated for ISS as part of the REAL8 clinical trial.

The CHMP opinion follows a prior recommendation in May 2026 for Sogroya to treat short stature in children born small for gestational age and those with Noonan Syndrome. The European Commission is now expected to issue a marketing authorization decision covering all three indications later this year.

"For too long, treatment options for many children with growth disorders have been limited," said Martin Holst Lange, executive vice president and chief scientific officer at Novo Nordisk. "Today's approval recommendation from the CHMP is a very important step forward for children and their families affected by ISS across Europe."

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