Novo Gets EU Regulator Backing to Expand Label of Growth-Hormone Treatment
By Adria Calatayud
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.
The EMA committee earlier this year backed granting marketing authorizations for Sogroya for the treatment of short stature in children born small for gestational age and the genetic condition Noonan Syndrome. Novo said it expects the European Commission, the EU's executive arm, to decide on the drug's approval for all three indications later this year.
The drug is already approved in the European Union for the treatment of growth-hormone deficiency in adults and children, Novo said.
Write to Adria Calatayud at adria.calatayud@wsj.com
(END) Dow Jones Newswires
September 18, 2026 07:16 ET (11:16 GMT)
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