FDA approves once-weekly Sogroya for children with growth disorders

The FDA has approved somapacitan-beco (Sogroya; Novo Nordisk) 5 mg, 10 mg, and 15 mg injections for children aged at least 2.5 years with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) without catch-up growth by the age of 2 years, and growth failure associated with Noonan Syndrome (NS).

This approval marks the first long-acting growth hormone to support children with these 3 indications in the United States. Somapacitan-beco has also been approved for children aged at least 2.5 years with growth hormone deficiency. This is a once-weekly option, helping children and caregivers who struggle with daily injections for hormone treatment.

"Families and health care 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," said Aristides Maniatis, MD, FAAP, founder of Rocky Mountain Pediatric Endocrinology.

Positive efficacy data for somapacitan-beco was reported in 3 sub studies from the REAL8 trial. At week 52, significant improvements were reported for all 3 conditions in children aged at least 2.5 years.

When compared with daily somatropin, somapacitan-beco displayed non-inferiority in mean annualized height velocity (AHV) among children with ISS, at 10.5 vs 10.2 cm per year. For children with SGA and no catch up by 2.5 years, the AHV from somapacitan-beco was 11 cm per year, vs 9.4 and 11.1 cm per year from the 2 growth hormones assessed.

Finally, non-inferiority was reported for somapacitan-beco in the AHV of children with NS compared to daily somatropin, at 10.4 vs 9.2 cm per year, respectively. Across all 3 indications, 10% or more of patients reported the following adverse events from somapacitan-beco:

• Respiratory tract infection
• Nasopharyngitis
• Ear infection
• Diarrhea

In ISS and NS patients, at least 10% receiving somapacitan-beco presented with headache. Additionally, injection site reactions were reported in at least 10% of ISS patients taking somapacitan-beco, while cough and headache were reported in at least 10% of NS and SGA patients.

"Sogroya is an effective alternative to daily injections that supports children's growth goals and may help fit into their routine,” said Maniati.

Reference

FDA approves Novo Nordisk's Sogroya as the first and only once-weekly, long-acting growth hormone for three additional pediatric indications. Novo Nordisk. February 27, 2026. Accessed February 27, 2026. https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-sogroya-as-the-first-and-only-once-weekly-long-acting-growth-hormone-for-three-additional-pediatric-indications-302699946.html