Novo Nordisk

Investigational phase 3 data for Sogroya® (somapacitan) injection in children with growth hormone deficiency presented today at the ENDO 2022 Congress1 ...

Sogroya® (somapacitan) injection is a prescription human growth hormone analogue medicine, similar to the growth hormone made by the body, and is used to treat adults who do not make enough growth hormone. Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. Novo Nordisk employs about 49,300 people in 80 countries and markets its products in around 170 countries. The most common AEs observed in ≥5% were events commonly observed in children, including headache, nasopharyngitis, pyrexia, pain in extremity, bronchitis and vomiting.1 Sogroya® is approved for the replacement of endogenous growth hormone in adults with growth hormone deficiency (AGHD) in the US, Europe, Japan, Australia, and Saudi Arabia. The use of Sogroya® in children with GHD is investigational and not approved.8, 9 7 ClinicalTrials.gov. A Research Study in Children with a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (NCT03811535). Available from: https://clinicaltrials.gov/ct2/show/NCT03811535?term=REAL4&draw=2&rank=1. Accessed: April 2022. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. The REAL 4 (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 disorders.7 Atlanta, Georgia (US), 12 June 2022 – Today, Novo Nordisk announced results of once-weekly Sogroya® (somapacitan) injection in helping children achieve growth targets of annualised height velocity (AHV).1 These phase 3 results from the REAL 4 study, in prepubertal children with growth hormone deficiency (GHD), were presented today at the Endocrine Society’s Annual Meeting (ENDO 2022) in Atlanta, Georgia (US). REAL 4 is a randomised, multi-national, open label, active-controlled parallel group phase 3 trial, comprising a 52-week main phase followed by a three-year extension period.1 Two-hundred growth hormone (GH) treatment naïve, prepubertal children with GHD (74.5% male) were randomly assigned in a 2:1 ratio to receive weekly subcutaneous 0.16 mg/kg/week Sogroya® (n=132) or daily subcutaneous 0.034 mg/kg/day somatropin (Norditropin®) (n=68).1 In the phase 3 study, REAL 4, Sogroya® showed a not significantly different AHV of 11.2 cm/year, compared to 11.7 cm/year for Norditropin®. Based on the main phase results of REAL 4, once-weekly Sogroya® was shown to work as well as daily Norditropin® for children with GHD, meeting its primary endpoint of non-inferiority. Investigational phase 3 data for Sogroya® (somapacitan) injection in children with growth hormone deficiency presented today at the ENDO 2022 Congress1 “The existing treatment options available for children with growth hormone deficiency require daily injections for many years,” said Dr. Bradley Miller, MD, PhD, Division of Pediatric Endocrinology, University of Minnesota Masonic Children's Hospital. “Based on the results of the REAL 4 study, there is potential for a once-weekly option for children with growth hormone deficiency.”