FDA approved three new pediatric indications for Novo Nordisk’s once-weekly Sogroya (somapacitan-beco) injection, expanding its use to children aged 2.5 years and older with ISS and short stature SGA, without catch-up growth by age 2, and growth failure associated with NS.

Sogroya is also indicated for children aged 2.5 years and older and adults with growth hormone deficiency (GHD).¹ The therapy (available in 5 mg, 10 mg, and 15 mg doses) is a long-acting human growth hormone analogue administered once weekly by subcutaneous injection.

“Daily injections have defined the growth disorder treatment paradigm for more than 40 years. Our scientific leadership and focus on advancing care in rare diseases led us to the development of Sogroya, a once-weekly growth hormone therapy, which may help address the challenge of daily injections while offering patients and families a therapeutic option that delivers efficacy and safety,” said Nicky Kelepouris, US medical lead of rare endocrine disorders at Novo Nordisk. “These new approvals expand the patient populations that can be helped by Sogroya and reflect our strategic focus on delivering meaningful, evidence-based innovation for children living with growth disorders.”

What is FDA’s approval of Sogroya based on?

Sogroya’s approval is supported by data collected from REAL8, a Phase III basket study evaluating once-weekly Sogroya in growth hormone treatment-naïve, pre-pubertal pediatric patients.²

Across three sub-studies, Sogroya met its primary endpoint, demonstrating non-inferiority to once-daily growth hormone therapy in mean annualized height velocity (AHV) at Week 52.²

In children with ISS, Sogroya demonstrated non-inferiority compared with daily somatropin (10.2 cm/year vs. 10.5 cm/year). In children born SGA with no catch-up growth by age 2, Sogroya showed a mean AHV of 11.0 cm/year compared with 9.4 cm/year and 11.1 cm/year for two daily growth hormone dosing regimens.² In children with growth failure associated with NS, Sogroya achieved a mean AHV of 10.4 cm/year compared with 9.2 cm/year for daily somatropin.²

“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,” said Dr. Aristides Maniatis, founder of Rocky Mountain Pediatric Endocrinology and an investigator in the trial. “Sogroya is an effective alternative to daily injections that supports children's growth goals and may help fit into their routine.”

What were the adverse reactions of Sogroya?

In REAL8, adverse reactions occurred in at least 10% of patients treated with Sogroya across the three indications included respiratory tract infection, nasopharyngitis, ear infection and diarrhea.² Additional reactions occurring in at least 10% of patients included headache in ISS and NS; cough, pyrexia and vomiting in NS and SGA; and injection site reaction in ISS.

Novo Nordisk has also submitted a supplemental application seeking U.S. approval of Sogroya for Turner Syndrome, with a regulatory decision expected later this year.

Sources

1. 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 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
2. Novo Nordisk A/S: Once-weekly Sogroya (somapacitan) is an efficacious and well-tolerated long-acting growth hormone in children with growth disorders: results from REAL8 phase 3 basket study presented at the joint Congress of ESPE and ESE. Novo Nordisk May 12, 2025 https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916003