Shots:
- The U.S. FDA has accepted the NDA for Novo‘s CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg) to support long-term weight loss & maintenance in adults with obesity or overweight & ≥1 related comorbidity, alongside lifestyle intervention
- NDA was supported by the P-III (REDEFINE 1) trial assessing CagriSema (QW) vs semaglutide 2.4mg alone, cagrilintide 2.4mg alone, or PBO with lifestyle intervention in 3,417 obese/overweight pts w/o diabetes & P-III (REDEFINE 2) trial of CagriSema vs PBO in 1,206 T2D adults with obesity/overweight
- In REDEFINE-1, CagriSema achieved 20.4% weight loss vs 3% (PBO) at 68wks. (treatment-regardless), & 22.7% vs 2.3% when assuming all pts stayed on therapy. 91.9% achieved ≥5% weight loss, & 54% reached non-obese BMI (<30 kg/m²) vs 31.5% & 11.1% with PBO
Ref: Novo Nordisk| Image: Novo Nordisk |Press Release
Related News: Novo Nordisk Reports the US FDA’s sNDA Submission for Higher Wegovy Dose for Weight Management
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