Novo Nordisk's Long-Acting Growth Hormone Sogroya Meets Primary Endpoint in Phase 3 Trial for Pediatric GHD

Recently, Novo Nordisk announced the Phase 3 clinical trial data of Sogroya (somapacitan) for the treatment of children with growth hormone deficiency (GHD) at the 2022 Endocrine Society Annual Meeting (ENDO). The relevant data showed that weekly injection of Sogroya has the potential to help pediatric patients achieve their growth target in annual height velocity (AHV).

GHD is a serious rare disease caused by the pituitary gland's inability to produce sufficient growth hormone, affecting approximately 1 in 3,500 to 1 in 10,000 children. Children with GHD not only experience short stature but also undergo metabolic abnormalities.

Sogroya Injection is a long-acting analog of human growth hormone (hGH) used to treat adult growth hormone deficiency (AGHD). Sogroya has been approved in the United States, Europe, Japan, and other countries and regions as a replacement for endogenous growth hormone in patients with AGHD. The use of Sogroya for treating GHD in pediatric patients is still under research and has not been approved.

REAL 4 Study Aims to Evaluate the Efficacy and Safety of Sogroya Injection in Pediatric Patients with GHD. It is a Randomized, Multinational, Open-Label, Active-Controlled Phase 3 Clinical Trial, Including a 52-Week Main Phase and a 3-Year Extension Period. A total of 200 treatment-naïve pediatric patients with GHD (74.5% male) were randomly assigned in a 2:1 ratio to receive either subcutaneous Sogroya 0.16 mg/kg/week (n=132) or subcutaneous Norditropin 0.034 mg/kg/day (n=68). In the Phase 3 REAL 4 study, the AHV for Sogroya was 11.2 cm/year, which was not significantly different from 11.7 cm/year for Norditropin. The main phase results of REAL 4 demonstrated that once-weekly Sogroya was as effective as once-daily Norditropin in pediatric patients with GHD, achieving its primary endpoint of non-inferiority.

"We are excited about the phase 3 results of REAL 4, which show that treatment with weekly Sogroya is as effective as daily Norditropin injections," said Mr. Martin Lange, Executive Vice President and Head of Development at Novo Nordisk. "Sogroya demonstrates Novo Nordisk's commitment to patients with rare endocrine disorders and our ongoing vision to provide innovative treatment 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

Original Title: Increase the Growth Rate of Children's Height, Novo Nordisk's Long-Acting Growth Hormone Achieves Primary Endpoint in Phase 3 Clinical Trial

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