Novo Nordisk Reports the US FDA Approval of Oral Wegovy for Weight Management
Shots:
- FDA has approved Wegovy (25mg, QD, PO) for weight loss, chronic weight management & major adverse CV events risk reduction in adults with obesity/overweight; US availability expected in early Jan 2026. Regulatory filing is made to the EMA & other authorities in H2’25
- Approval was based on the P-IIIb (OASIS 4) trial assessing oral Wegovy vs PBO over 64wks. in 307 adults with obesity or overweight with ≥1 comorbidities, & SELECT trial
- OASIS 4 showed oral Wegovy resulted in 16.6% mean weight loss in treatment-adherent adults & the loss was similar to that of injectable Wegovy, plus 1 in 3 pts experienced ≥20% weight loss
Ref: Novo Nordisk | Image: Novo Nordisk |Press Release
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