Novo Nordisk announced late Friday that the US Food and Drug Administration has approved three new pediatric indications for its once-weekly long-acting growth hormone Sogroya (somapacitan-beco), available in 5 mg, 10 mg, and 15 mg injection strengths. The expanded label allows treatment of additional pediatric populations while maintaining the existing indication for growth hormone deficiency in both children aged 2.5 years and older and adults.
Under the updated approval, Sogroya is indicated for:
- Children aged 2.5 years and older with Idiopathic Short Stature (ISS).
- Children aged 2.5 years and older who were born Small for Gestational Age (SGA) and have not achieved catch-up growth by 2 years of age.
- Children aged 2.5 years and older with growth failure associated with Noonan Syndrome (NS).
The company noted that Sogroya continues to be indicated for children aged 2.5 years and older and adults with growth hormone deficiency.
In a statement explaining the rationale behind developing a once-weekly option, Nicky Kelepouris, Rare Endocrine Disorders-US Medical Lead at Novo Nordisk, highlighted the longstanding reliance on daily injections in treating growth disorders and positioned Sogroya as an alternative that may ease the burden of daily administration while delivering established efficacy and safety for children with growth disorders. The company emphasized that these approvals extend the patient groups eligible for this weekly therapy.
Adherence to daily growth hormone injections can be demanding for children and caregivers. Novo Nordisk pointed out that daily regimens amount to 365 injections per year, while a once-weekly dosing schedule results in 313 injection-free days annually for patients using Sogroya.
Dr. Aristides Maniatis, founder of Rocky Mountain Pediatric Endocrinology in Centennial, Colorado, and an investigator in the pivotal program, said the once-weekly option gives families and clinicians an alternative to daily injections, offering 313 injection-free days per year for children aged 2.5 years and older with ISS, NS, and those born SGA. He described Sogroya as an effective alternative that can support children’s growth goals and integrate into daily routines.
The regulatory decisions were supported by the REAL8 pivotal study, which was structured with three substudies corresponding to the three newly approved pediatric indications. According to Novo Nordisk, each substudy met its primary endpoint, demonstrating that once-weekly Sogroya was non-inferior to once-daily growth hormone therapy for mean annualized height velocity at Week 52 across the three pediatric indications in children aged 2.5 years and older.
Study results reported by the company include the following mean annualized height velocities at Week 52:
- Idiopathic Short Stature: Sogroya achieved 10.2 centimeters per year versus 10.5 centimeters per year for once-daily somatropin. The daily comparator dose used in this cohort was 0.05 milligrams per kilogram per day, which is below the maximum approved pediatric dose of 0.067 milligrams per kilogram per day in the United States.
- Small for Gestational Age with no catch-up by 2 years: Sogroya showed a mean annualized height velocity of 11.0 centimeters per year versus 9.4 centimeters per year with a daily somatropin dose of 0.035 milligrams per kilogram per day and 11.1 centimeters per year with a daily dose of 0.067 milligrams per kilogram per day. The lower daily dose of 0.035 milligrams per kilogram per day is below the US maximum approved pediatric dose of 0.067 milligrams per kilogram per day.
- Noonan Syndrome: Sogroya demonstrated a mean annualized height velocity of 10.4 centimeters per year compared with 9.2 centimeters per year for once-daily somatropin. The daily somatropin dose used in this cohort was 0.05 milligrams per kilogram per day, reported as lower than the maximum approved pediatric dose of 0.066 milligrams per kilogram per day in the US.
Safety data from the REAL8 program reported adverse reactions occurring in at least 10% of patients treated with Sogroya across all three indications. These events included respiratory tract infection, nasopharyngitis, ear infection, and diarrhea. Additional adverse reactions observed in at least 10% of patients were headache in the Idiopathic Short Stature and Noonan Syndrome groups; cough, pyrexia, and vomiting in the Noonan Syndrome and Small for Gestational Age groups; and injection site reaction in the Idiopathic Short Stature group.
Separately, Novo Nordisk has filed a supplemental application seeking approval of Sogroya for Turner Syndrome in the United States. The company stated that a decision on that application is expected later this year.
These approvals broaden the pediatric label for a once-weekly somapacitan-beco option and hinge on the pivotal REAL8 data showing non-inferiority in annualized height velocity compared with daily somatropin across multiple pediatric growth disorder populations. The label expansion affects pediatric endocrinology practice and impacts families managing long-term injectable therapy schedules for children with growth disorders.