FDA Approves 3 New Pediatric Indications for Once-Weekly Somapacitan-beco (Sogroya)

The US Food and Drug Administration (FDA) has approved 3 new indications for Novo Nordisk’s once-weekly somapacitan-beco (Sogroya) injection 5 mg, 10 mg, or 15 mg.

With the approval, the long-acting growth hormone is now indicated for children ≥ 2.5 years of age with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS). Somapacitan is additionally indicated for children ≥ 2.5 years of age and adults with growth hormone deficiency (GHD).

"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 Aristides Maniatis, MD, founder of Rocky Mountain Pediatric Endocrinology and an investigator in the REAL8 trial supporting the approvals. "[Somapacitan] is an effective alternative to daily injections that supports children's growth goals and may help fit into their routine."

Once-weekly somapacitan injection is a prescription human growth hormone analogue that has previously been approved in the US for the replacement of endogenous growth hormone in adults with growth hormone deficiency in August 2020 and for pediatric patients ≥ 2.5 years of age with growth failure due to inadequate secretion of endogenous growth hormone in April 2023.

The latest indications for children ≥ 2.5 years of age with ISS, short stature born SGA and with no catch-up growth by 2 years of age, and growth failure associated with NS were supported by data from the REAL8 study as part of the ongoing REAL clinical trial program.

The multi-center, randomized, open-label, active-comparator, phase 3 basket study is being conducted in growth hormone treatment-naïve, pre-pubertal pediatric patients with short stature born SGA, NS, or ISS. The primary treatment period was 52 weeks, and the study is currently in a 2-year safety extension phase. Of note, this is the first time a trial design of this type has been implemented in the growth disorder space.

In the study, 142 pediatric patients aged 2.6 to 10.7 years with SGA were randomly assigned to somapacitan 0.24 mg/kg/week (n = 70), once-daily somatropin 0.035 mg/kg/day (n = 37), or once-daily somatropin 0.067 mg/kg/day (n = 35). Additionally, 77 pediatric patients aged 2 to 11.1 years with NS were randomized to somapacitan 0.24 mg/kg/week (n = 49) or once-daily somatropin 0.05 mg/kg/day (n = 28), and 88 pediatric patients aged 2.8 to 10.8 years with ISS were randomized to 0.24 mg/kg/day (n = 60) or once-daily somatropin 0.05 mg/kg/day (n = 28).

As described in the press release, all 3 sub studies achieved their primary endpoint, demonstrating that once-weekly somapacitan injection 5 mg, 10 mg, or 15 mg was non-inferior to once-daily growth hormone treatment for mean annualized height velocity (AHV) at week 52.

Specifically, in children with ISS, somatropin demonstrated non-inferiority in mean AHV compared with daily somatropin (10.2 vs 10.5 cm/year). The dose of 0.05 mg/kg/day of daily somatropin is less than maximum dose approved dose (0.067 mg/kg/day) for use in pediatric patients in the US.1

In children born SGA with no catch up by 2 years of age, somatropin demonstrated non-inferiority compared to both daily growth hormone doses (0.035 mg/kg/day and 0.067 mg/kg/day) with a mean AHV of 11.0 cm/year vs 9.4 cm/year vs 11.1 cm year respectively; daily growth hormone dose of 0.035 mg/kg/day is less than the maximum approved dose (0.067 mg/kg/day) in the US.

In children with growth failure associated with NS, somatropin demonstrated non-inferiority in mean AHV compared to daily somatropin (10.4 vs 9.2 cm/year); the daily somatropin dose of 0.050 mg/kg/day used is less than the maximum approved dose (0.066 mg/kg/day) in the US.

In REAL8, the adverse reactions occurring in ≥10% of patients treated with somatropin across all 3 indications were respiratory tract infection, nasopharyngitis, ear infection, and diarrhea. Additional reactions occurring in ≥10% of patients treated with somatropin included headache in ISS and NS; cough, pyrexia, and vomiting in NS and SGA; and injection site reaction in ISS.

"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 [somatropin] – 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, Rare Endocrine Disorders-US Medical Lead. "These new approvals expand the patient populations that can be helped by [somatropin] and reflect our strategic focus on delivering meaningful, evidence‑based innovation for children living with growth disorders."

Novo Nordisk additionally noted the submission of a supplemental application for somatropin for approval in the US for Turner Syndrome, with a decision expected later in 2026.

References

1. Novo Nordisk. FDA approves Novo Nordisk's Sogroya® as the first and only once-weekly, long-acting growth hormone for three additional pediatric indications. 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

2. FDA. FDA approves weekly therapy for adult growth hormone deficiency. September 1, 2020. Accessed February 27, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-weekly-therapy-adult-growth-hormone-deficiency

3. Fitch J. FDA expands approval of somapacitan-beco injection to children with growth hormone deficiency. Contemporary Pediatrics. May 1, 2023. Accessed February 27, 2026. https://www.contemporarypediatrics.com/view/fda-expands-approval-of-somapacitan-beco-injection-to-children-with-growth-hormone-deficiency#:~:text=%7CArticles%7CMay%201%2C%202023,for%20other%20growth%2Dassociated%20problems.