CHMP positive opinion, recommending once-weekly Sogroya for replacement of endogenous growth hormone (GH) in children aged three years and above, and adolescents with growth failure due to growth hormone deficiency.- Novo Nordisk.
Novo Nordisk 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 opinion is based on data from the phase III 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
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