(News Bulletin 247) – Novo Nordisk announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending Sogroya (somapacitan), administered once a week, to replace endogenous growth hormone in children and adolescents with growth retardation due to hormone deficiency.
“We hope Sogroya will help improve the lives of children as young as three years old by providing an easier treatment option with fewer injections,” said Martin Holst Lange, executive vice president of development at Novo Nordisk. .
The phase 3 REAL4 study showed that injecting Sogroya subcutaneously once a week worked as well as injecting Norditropin daily. This means that at the end of the trial period, prepubertal children treated with Sogroya once a week had similar growth to children treated with Norditropin once a day.
The European Commission (EC) will now review the positive CHMP opinion and a final decision on marketing authorization is expected in the coming months. If approved, Sogroya will be available in select European countries from Q4 2023. It received US Food & Drug Administration (FDA) approval in April 2023.
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