Shots:
- The P-III (REAL8) basket trial assessed Sogroya (0.24mg/kg, QW or 0.05 mg/kg, QD) in pre-pubertal children with NS, TS, or ISS; SGA-born children were randomized to Sogroya 0.24mg/kg QW or QD dosing (0.035 or 0.067mg/kg)
- Trial met its 1EP, showing QW dosing was non-inferior to GH therapy (QD) at Wk. 52, with superior HV in SGA (11.0 vs 9.4 cm/yr.) vs 0.035 mg/kg/day & in NS (10.4 vs 9.2 cm/year), plus non-inferior HV in SGA (11.0 vs 11.1 cm/yr.) compared to 0.067 mg/kg/day & in ISS (10.5 vs 10.5 cm/yr.); data was shared at ESPE & ESE 2025, plus TS data to be reported by late 2025
- In April 2025, regulatory filings of Sogroya for SGA, NS, & ISS was submitted to the US FDA & EMA based on REAL8 & P-III (REAL9) trial data
Ref: Novo Nordisk | Image: Novo Nordisk
Related News:- Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click Here for Full Press Release
