The US FDA has approved Novo Nordisk’s once-weekly growth hormone somapacitan-beco (Sogroya) for three new pediatric indications. 

The injectable long-acting growth hormone, in doses of 5 mg, 10 mg, and 15 mg, is now indicated for children aged 2.5 years or older with idiopathic short stature (ISS), those who were born small for gestational age (SGA), and for those with Noonan Syndrome (NS). 

The product was first approved in August 2020 for adults with growth hormone deficiency (GHD), and then in April 2023 for GHD in children. Other once-weekly growth hormone products are currently available in the US for pediatric patients with GHD, but Sogroya now has the “broadest range of approved indications among long-acting growth hormones,” according to a Novo Nordisk statement. 

The approval was based on findings from the first year of REAL8, a multicenter, randomized, open-label active comparator phase 3 clinical trial, which is now in a 2-year safety extension phase. There were three substudies, enrolling 142 children with SGA, 77 with NS, and 88 with ISS, respectively. 

In each substudy, somapacitan-beco demonstrated noninferiority to less-than-maximal once-daily doses of somatotropin for mean annualized height velocity at week 52.

The most common side effects in children include cough, common cold, diarrhea, ear infection, headache, fever, pain in extremity, reaction to injection, respiratory tract infection, and vomiting. 

In the statement, study investigator Aristides K. Maniatis, founder of Rocky Mountain Pediatric Endocrinology, Centennial, Colorado, said, “Families and healthcare professionals now have the option to consider a once-weekly growth hormone as treatment with 313 injection-free days per year for their children 2.5 years and older with ISS, NS, and born SGA. Sogroya is an effective alternative to daily injections that supports children’s growth goals and may help fit into their routine.”

Novo Nordisk has also submitted a supplemental application in the US for Sogroya for treating children with Turner syndrome. A decision is expected later this year.

Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X @MiriamETucker and BlueSky @miriametucker.bsky.social.