Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion for the company’s Sogroya therapy.
The once-weekly treatment – also known as somapacitan – is for the replacement of endogenous growth hormone (GH) in aged children three years and older. It can also be used to treat adolescents with growth failure due to growth hormone deficiency.
The positive opinion has emerged following data from Novo Nordisk’s phase 3 ‘REAL4’ trial, which demonstrated that a once-weekly subcutaneous injection of Sogroya worked as effectively as a daily injection of Norditropin.
By the conclusion of the trial period, prepubertal children who were treated with once-weekly Sogroya had achieved similar growth as children who were treated with Norditropin.
Martin Holst Lange, executive vice president for development at Novo Nordisk, was optimistic about the verdict: “Today’s positive CHMP opinion is a step forward to reducing the impact of growth hormone deficiency for children, adolescents and their families in Europe.”
He added: “We are hopeful that Sogroya will help improve the lives of children as young as three years old by offering a simpler treatment option with fewer injections in an easy-to-use device, whilst helping them to achieve their growth targets.”
Meanwhile, the European Commission (EC) will review the CHMP’s positive opinion and a final decision on marketing authorisation is expected later in the year. If approved, Sogroya will be available across some European countries by the end of 2023.
Growth hormone deficiency is a rare disease and a treatable cause of short stature – it is thought to impact around one in 3,500 to 10,000 children.
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