Medical Professionals Reference (MPR)Sogroya Approval Expanded to Include 3 Additional Pediatric Growth Disorders

The FDA expanded Sogroya (somapacitan-beco) approval to cover three additional pediatric indications in children aged 2.5 and older: short stature born SGA with no catch-up growth, Noonan syndrome, and idiopathic short stature. Once-weekly dosing delivered 313 injection-free days per year compared to daily somatropin.

Professional Impact

• Phase 3 REAL8 trial demonstrated noninferiority to daily somatropin across all three cohorts at 52 weeks, with AHV ranging from 10.2 to 11.0 cm/year with somapacitan versus 9.2 to 11.1 cm/year with comparator doses
• Noonan syndrome patients showed the greatest height SDS gain with somapacitan (1.06) versus daily somatropin (0.79) at 52 weeks, though ISS patients showed a slight advantage with daily dosing (0.98 vs 1.09)
• Common adverse reactions were consistent with the known somatropin safety profile: respiratory tract infection, nasopharyngitis, ear infection, and diarrhea; no new safety signals identified
• Approval covers treatment-naïve, pre-pubertal patients only; efficacy in previously treated or pubertal children was not evaluated in REAL8

Action Items

• Identify eligible patients aged 2.5 and older with SGA, Noonan syndrome, or ISS currently on or being considered for growth hormone therapy
• Counsel families on the once-weekly schedule as a concrete alternative to daily injections, particularly for adherence-challenged patients
• Coordinate with pediatric endocrinology before initiating; somapacitan requires weight-based dosing (0.24 mg/kg/week) and monitoring protocols
• Review the prefilled pen’s three available concentrations (3.3, 6.7, and 10 mg/mL) to ensure appropriate strength selection by weight

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