FDA

FDA greenlights Sogroya for 3 new pediatric indications

March 6, 2026

On February 27, 2026, FDA approved Sogroya (somapacitan-beco), a long-acting human growth hormone analog, for the treatment of pediatric patients aged ≥2.5 years with:

• short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age
• idiopathic short stature (ISS)
• growth failure associated with Noonan syndrome (NS)

Previously, Sogroya was approved for growth hormone deficiency (GHD) in adults and children ≥2.5 years old.

Efficacy

Approval of the three new indications was based on a multi-center, randomized, open-label, active-comparator, phase 3 basket study (REAL8) in growth hormone treatment-naïve, pre-pubertal pediatric patients with short stature in SGA, ISS, or NS. The primary efficacy endpoint was annualized height velocity (AHV) at week 52.

Patients with SGA (n=142) were randomized to once-weekly Sogroya 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). SGA patients ranged in age from 2.6 to 10.7 years with a mean of 5.5 years.

Patients with NS or ISS (NS: n=77; ISS: n=88) were randomized to once-weekly Sogroya at a dose of 0.24 mg/kg/week (NS: n=49; ISS: n=60) or once-daily somatropin at a dose of 0.05 mg/kg/day (NS: n=28; ISS: n=28). NS patients were aged 2 to 11.1 years (mean 6.2), and ISS patients were aged 2.8 to 10.8 years (mean 6.9).

For all three indications, once-weekly Sogroya demonstrated noninferiority compared with daily somatropin arms:

• SGA cohort: Sogroya was noninferior 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. The estimated treatment difference was 1.6 cm/year (95% CI, 0.91, 2.23) vs. somatropin 0.035 mg/kg/day and and -0.1 cm/year (95% CI, -0.75, 0.60) vs. somatropin 0.067 mg/kg/day.
• ISS cohort: AHV of 10.2 vs. 10.5 cm/year, with an estimated treatment difference of-0.3 (95% CI, -1.00, 0.42).
• NS cohort: AHV of 10.4 vs. 9.2 cm/year, with an estimated treatment difference of 1.2 (95% CI, 0.32, 2.03).

Safety

Common adverse reactions (≥10%) across all three indications were respiratory tract infection, nasopharyngitis, ear infection, and diarrhea. Additional reactions reported in ≥10% of patients were:

• In SGA: cough, pyrexia, vomiting
• In ISS: injection site reaction, headache
• In NS: headache, cough, pyrexia, vomiting

Sources:

Novo Nordisk. (2027, February 27). FDA approves Novo Nordisk's Sogroya as the first and only once-weekly, long-acting growth hormone for three additional pediatric indications. [Press release]. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916507

Sogroya (somapacitan-beco). [Package insert]. Novo Nordisk. https://www.novo-pi.com/sogroya.pdf Revised February 2026.