Shots:
- The US FDA has received an sNDA for a higher dose of Wegovy (7.2mg semaglutide) along with lifestyle intervention for chronic weight management in adults with obesity, with sNDA to be reviewed under CNPV program
- sNDA was supported by 72wk. STEP UP trial assessing Wegovy (7.2mg, QW) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 obese adults without diabetes (BMI ≥30kg/m²)
- Study showed superior weight loss of 20.7% (7.2mg) vs 17.5% (2.4mg) & 2.4% (PBO), as well as 33.2% vs 16.7% & 0% achieved ≥25% weight loss after 72wks. With the treatment policy estimand, weight losses were 18.7% vs 15.6% & 3.9%, plus 90.7% pts achieved ≥5% weight loss vs 89.9% & 36.8%, while 31.2% reached ≥25% loss vs 15.3%
Ref: Novo Nordisk | Image: Novo Nordisk | Press Release
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