Denmark: Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending once-weekly Sogroya (somapacitan) for replacement of endogenous growth hormone (GH) in children aged three years and above, and adolescents with growth failure due to growth hormone deficiency.
Symptoms of growth hormone deficiency in children often start early in life, leading to short stature as well as other growth-related health problems. Current treatment for growth hormone deficiency typically requires daily injections of growth hormone. However, frequent injections can be burdensome, disrupting daily life, reducing adherence and thereby affecting clinical outcomes – particularly in children.
“The positive CHMP opinion is a step forward to reducing the impact of growth hormone deficiency for children, adolescents and their families in Europe,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “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.”
The positive opinion is based on data from the phase 3 REAL4 study, which showed that once-weekly subcutaneous injection of Sogroya worked as well as daily injection of Norditropin (somatropin). This means that at the end of the trial period, prepubertal children who were treated with once-weekly Sogroya achieved similar growth as children who were treated with once-daily Norditropin.
The European Commission (EC) will now review the CHMP’s positive opinion, and a final decision on the marketing authorisation is expected in the coming months. If approved, Sogroya will be available in some European countries starting in Q4 2023. It received approval from the US Food & Drug Administration (FDA) in April 2023.
Sogroya is a prescription human growth hormone analogue, similar to current daily growth hormone and can be used to treat adults who do not produce enough growth hormone. Sogroya was approved in the EU for the replacement of endogenous growth hormone in adults with growth hormone deficiency (AGHD) in 2021.
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