Shots:
- The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA: Q4’25)
- Submission was based on the P-III (OASIS 4) trial assessing oral Wegovy (25mg; OD) vs PBO over 64wks. (incl. 12wk. dose escalation & 7wk. off-treatment follow-up) in 307 adults with obesity (BMI ≥ 30kg/m2) or overweight (BMI ≥ 27kg/m2) & comorbidities (excl. diabetes)
- Wegovy (semaglutide; 2.4mg injection) is approved for chronic weight management & CV risk reduction in obese or overweight pts (≥12yrs.), with reduced-calorie diet & increased physical activity
Ref: Prnewswire| Image: Novo Nordisk
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