FDA Approves Once-Weekly Sogroya® for the Treatment of Children Living with Growth Hormone Deficiency

The U.S. Food and Drug Administration (FDA) last month approved a new indication for somapacitan-beco injection 5 mg, 10 mg, or 15 mg for the treatment of children aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone. Novo Nordisk is marketing the treatment as Sogroya®

The FDA approval of the new indication for children with GHD is based on data from the phase 3 REAL4 study. In the study, two hundred treatment-naïve patients aged 2.5 – 11 years with GHD were either given once-weekly Sogroya® (n=132) or daily somatropin (n=68) for 52 weeks. The results showed that Sogroya® was comparable to daily somatropin for the primary endpoint of annualized height velocity (11.2 cm/year vs. 11.7 cm/year, respectively). Adverse reactions in the REAL4 study occurring in more than 5% of patients included nasopharyngitis, headache, pyrexia, pain in extremity, and injection site reactions.

Children with GHD typically experience short stature and can also have an increased risk for other growth-associated problems.  For decades, GH replacement has been the standard of care to improve growth outcomes. Patients may struggle with a daily injection routine over the long term, and according to the Growth Hormone Research Society consensus, a once-weekly GH option offers patients and families a therapeutic alternative.

Sogroya® leverages albumin-binding technology developed by Novo Nordisk for other disease areas. It binds to endogenous albumin, which delays elimination of somapacitan-beco and thereby prolongs the in vivo half-life and duration of action.

The Sogroya® pen is based on the FlexPro® pen, which has more than 10 years of patient experience. Sogroya® will be provided in a prefilled, premixed, portable pen that is stable at room temperature (up to 77oF) for up to a maximum of 72 hours.

Novo Nordisk plans to make Sogroya® available for both pediatric and adult patients in the coming months.