Shots:
- The US FDA has approved a label extension for Wegovy to treat noncirrhotic MASH in adults with mod. to adv. liver fibrosis (F2 to F3 fibrosis) in combination with a reduced calorie diet & increased physical activity; Application submitted to EMA & PMDA in Feb & May 2025, respectively
- Approval was based on Part 1 of P-III (ESSENCE) trial (n=1200) of Wegovy (2.4 mg, QW, SC) vs PBO in MASH with stage 2/3 liver fibrosis, where part 1 assessed histologic improvement at 72wks. in 800 pts, & part 2 to evaluate reduction in liver-related clinical events at 240wks.; Part 2 data expected in 2029
- At 72wks., trial showed improvement in liver fibrosis with 36.8% vs 22.4% achieving fibrosis improvement without worsening steatohepatitis, & 62.9% vs 34.3% achieving steatohepatitis resolution without fibrosis worsening
Ref: Novo Nordisk | Image: Novo Nordisk | Press Release
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