Novo Nordisk long-acting growth hormone meets primary endpoint of Phase 3 trials
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Novo Nordisk long-acting growth hormone meets primary endpoint of Phase 3 clinical trials.
On June 20, Novo Nordisk announced data from a Phase 3 clinical trial of Sogroya (somapacitan) in children with growth hormone deficiency (GHD) at the Endocrine Society Annual Meeting (ENDO) 2022.
Data suggest that weekly injections of Sogroya have the potential to help paediatric patients achieve their annual growth rate (AHV) growth goals.
GHD is a serious rare disease caused by the pituitary gland not producing enough growth hormone, affecting approximately 1 in 3500 to 1 in 10000 children.
Children with GHD not only have short stature, but also experience metabolic abnormalities.
Sogroya Injection is a long-acting analog of human growth hormone (hGH) used to treat adult growth hormone deficiency (AGHD).
Sogroya is approved in the United States, Europe, Japan and other countries and regions to replace endogenous growth hormone in patients with AGHD. The therapeutic use of Sogroya in pediatric patients with GHD is under investigation and not approved.
The REAL 4 study was designed to evaluate the efficacy and safety of Sogroya injection in children with GHD. It is a randomized, multinational, open-label, active-controlled Phase 3 clinical trial that includes a 52-week main phase and a 3-year extension period.
200 growth hormone-naïve children with GHD (74.5% men) were randomly assigned in a 2:1 ratio to receive subcutaneous Sogroya 0.16 mg/kg/week (n=132) or subcutaneous Norditropin 0.034 mg/kg/day (n=68).
In the phase 3 study of REAL 4, the AHV of Sogroya was 11.2 cm/yr, which was not significantly different from Norditropin’s 11.7 cm/yr.
Results from the primary phase of REAL 4 demonstrated that weekly injections of Sogroya were as effective as once-daily injections of Norditropin in children with GHD, meeting its primary endpoint of noninferiority.
“We are excited by the results of the Phase 3 study of REAL 4, which showed that weekly treatment with Sogroya was as effective as daily Norditropin injection,” said Mr. Martin Lange, Executive Vice President and Head of Development, Novo Nordisk. Sogroya demonstrates Novo Nordisk’s commitment to the rare endocrine disease patient population and our continued vision to provide innovative therapeutic solutions for all patient needs.”
References:
1.Novo Nordisk A/S: Sogroya® data show potential as once-weekly treatment in children living with growth hormone deficiency. Retrieved Jun 13, 2022, from https://www.novonordisk-us.com/media/news-archive/news-details.html?id=119935
Novo Nordisk long-acting growth hormone meets primary endpoint of Phase 3 trials
(source:internet, reference only)
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