FDA Approves Somapacitan for Additional Pediatric Growth Disorder Indications

The FDA has approved somapacitan-beco (Sogroya; Novo Nordisk) growth hormone injection for 3 additional pediatric indications, according to a news release from Novo Nordisk, expanding treatment options for children aged 2.5 years and older with growth disorders.¹

The approval encompasses patients with idiopathic short stature (ISS), short stature in children born small for gestational age (SGA) without catch-up growth by age 2 years, and growth failure associated with Noonan syndrome (NS). Somapacitan now holds the broadest range of approved indications among long-acting growth hormones in the United States.¹

REAL8 Trial Results

The approval was supported by data from REAL8 (NCT05330325), a multicenter, randomized, open-label, phase 3 basket trial demonstrating that once-weekly somapacitan was noninferior to once-daily somatropin (Norditropin; Novo Nordisk) for mean annualized height velocity (AHV) at week 52 across all 3 indications.^1-3

In children with ISS, somapacitan demonstrated noninferior mean AHV compared with daily somatropin (10.2 versus 10.5 centimeters per year [cm/year]). For children born SGA, somapacitan showed a noninferior mean AHV of 11.0 cm/year compared with the higher approved dose of daily somatropin (11.1 cm/year) and superior AHV compared with a lower dose (9.4 cm/year). In children with NS, somapacitan demonstrated superior mean AHV compared with daily somatropin (10.4 versus 9.2 cm/year).^1,2

The study enrolled 307 pediatric patients across 3 substudies: 142 children with SGA, 77 with NS, and 88 with ISS. Participants received either somapacitan 0.24 mg/kg once weekly or daily somatropin at doses ranging from 0.035 to 0.067 mg/kg depending on indication. The trial is currently in a 2-year safety extension phase.¹

Safety Profile

The safety profile of somapacitan was consistent with the known profile of growth hormone therapy. The most common adverse reactions occurring in 10% or more of patients across all 3 indications included respiratory tract infection, nasopharyngitis, ear infection, and diarrhea. Additional reactions occurring in 10% or more of patients in specific indications included headache in ISS and NS, cough and pyrexia in NS and SGA, vomiting in NS and SGA, and injection site reactions in ISS.^1,2

Understanding the Growth Disorders

The 3 newly approved indications represent distinct pediatric conditions affecting growth and development. ISS describes children who are shorter than their peers without an identifiable underlying medical cause. Children with ISS typically have normal birth weights, body proportions, and growth hormone levels, but their height falls more than 2 standard deviations below the mean for their age and sex. The diagnosis is made after excluding other causes of short stature, such as growth hormone deficiency or genetic disorders.⁴

Children classified as SGA are born with weight or length at least 2 standard deviations below the mean for gestational age. While approximately 85% to 90% of children born SGA achieve catch-up growth by age 2 years, the remaining 10% to 15% do not experience catch-up growth, and this height deficit typically persists through childhood and into adulthood. Children born SGA face increased risks for metabolic disruptions and developmental challenges beyond short stature.⁵

Noonan syndrome is a genetic disorder affecting approximately 1 in 1000 to 2500 infants. The condition can affect both males and females and is characterized by multiple features, including short stature, distinctive facial characteristics, and heart defects. About half of all Noonan syndrome cases result from a mutation on a gene located on chromosome 12.⁶

Addressing Treatment Adherence Challenges

Daily growth hormone injections have been the standard of care for more than 40 years, requiring 365 injections annually. Non-adherence represents a significant challenge in pediatric growth hormone therapy. Research indicates that approximately 25% of children receiving daily growth hormone treatment miss more than 2 injections per week. Missed doses can significantly impact treatment outcomes, with one year of missed treatment over a typical 7-year treatment period potentially affecting final adult height.^1,2,7

"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 a REAL8 trial investigator, in the news release.¹

Pharmacist Considerations

Pharmacists play essential roles in supporting families managing pediatric growth disorders. Key responsibilities include patient education on proper injection technique and storage requirements, counseling on the importance of adherence to weekly dosing schedules, monitoring for adverse effects, and coordinating care with pediatric endocrinologists.

Somapacitan is administered once weekly via subcutaneous injection at a dose of 0.24 mg/kg. Pharmacists must be aware that if a dose is missed, it can be administered within 72 hours after the scheduled dosing day, with the regular weekly schedule resuming on the next scheduled dosing day. If more than 3 days have passed, the missed dose should be skipped, and the next dose should be taken on the regularly scheduled day.¹

Growth hormone therapy represents a significant financial commitment for families, with annual costs exceeding tens of thousands of dollars. Insurance coverage varies widely depending on diagnosis and specific health plans. Pharmacists can assist families in navigating coverage issues, identifying patient assistance programs, and ensuring appropriate prior authorization documentation is submitted.⁴

The expansion of somapacitan indications provides clinicians and families with an important therapeutic option that may improve adherence and treatment outcomes while reducing the burden associated with daily injections. The once-weekly formulation addresses a longstanding challenge in pediatric growth hormone therapy and represents a meaningful advancement in treatment options for children with growth disorders.

REFERENCES

1. FDA approves Novo Nordisk's Sogroya as the first and only once-weekly, long-acting growth hormone for 3 additional pediatric indications. News release. Novo Nordisk. Published February 27, 2026. Accessed March 2, 2026. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916507

2. McGovern G. Sogroya observed as efficacious and well-tolerated in children with growth disorders. Pharmacy Times. Published May 22, 2025. Accessed March 2, 2026. https://www.pharmacytimes.com/view/somapacitan-observed-as-efficacious-and-well-tolerated-in-children-with-growth-disorders

3. A research study to compare somapacitan once a week with norditropin once a day in children who need help to grow (REAL 8). ClinicalTrials.gov Identifier: NCT05330325. Last Updated February 12, 2026. Accessed March 2, 2026. https://clinicaltrials.gov/study/NCT05330325

4. Yale Medicine. Short stature (growth disorders) in children. Accessed March 2, 2026. https://www.yalemedicine.org/conditions/short-stature-child

5. Jones A, Goldman J. Children with short stature born small for gestational age: pediatric primary care guide. Topical Reviews in Pediatrics. Published November 21, 2024. Accessed March 2, 2026. doi:10.26075/d-k998-f7k1

6. What is Noonan syndrome? Norditropin.com. Novo Nordisk. Accessed March 2, 2026. https://www.norditropin.com/understand-growth-disorders/types-of-growth-disorders/noonan-syndrome.html

7. Johannsson G, Feldt-Rasmussen U, Håkonsson IH, et al. Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial. Eur J Endocrinol. 2018;178(5):491-499. doi:10.1530/EJE-17-1073