Symptoms of growth hormone deficiency in children often start early in life, leading to short stature as well as other growth-related health problems.1 Current treatment for growth hormone deficiency typically requires daily injections of growth hormone.2 However, frequent injections can be burdensome, disrupting daily life, reducing adherence and thereby affecting clinical outcomes - particularly in children.3
'Today's positive CHMP opinion is a step forward to reducing the impact of growth hormone deficiency for children, adolescents and their families in
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.4
The
About the REAL4 study
The REAL4 (REversible ALbumin) study (NCT03811535) is part of the ongoing REAL clinical study programme and was designed to evaluate the efficacy and safety of Sogroya (somapacitan) injection in children with growth hormone deficiency.5 REAL4 is a randomised, multi-national, open label, active-controlled parallel group phase 3 trial, comprised of a 52-week main phase followed by a three-year extension period. Two-hundred growth hormone treatment naive, prepubertal children with growth hormone deficiency were randomly assigned in a 2:1 ratio to receive weekly subcutaneous injection of 0.16 mg/kg/week Sogroya (n=132) or daily subcutaneous injection of 0.034 mg/kg/day somatropin (Norditropin) (n=68).4 Results from the study showed that annualised height velocity (centimetres grown in a year) in children with growth hormone deficiency treated with once-weekly Sogroya was 11.2 cm/year, compared to 11.7 cm/year for daily Norditropin with no statistical difference between the two groups. Sogroya was well tolerated, with a similar safety and tolerability profile to the well-known profile of Norditropin.4
Growth hormone deficiency
Growth hormone deficiency is a rare disease and a treatable cause of short stature. It is estimated to affect approximately 1 in 3,500 to 10,000 children.6,7 Growth hormone is essential for growth, muscle and bone strength and it helps to control sugar and fat levels in the body. Growth hormone deficiency in children is characterised by slow growth from an early age and a markedly reduced final adult height compared to that predicted.8,9 Other symptoms can include reduction of bone mineral density, slow development of facial bones and long bones, and delayed appearance of teeth.1,10
About Sogroya (somapacitan)
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 2021.11
Contact:
Tel: +45 3079 9289
Email: abmo@novonordisk.com
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