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Novo Nordisk Seeks FDA Approval as Eli Lilly's Weight-Loss Pill Advances

Novo Nordisk files for FDA approval of its oral anti-obesity medication, following Eli Lilly's phase III success with orforglipron, the first oral GLP-1 to achieve this milestone.

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Overview

  • Novo Nordisk has formally applied to the FDA for approval of its oral anti-obesity medication, aiming to expand its GLP-1 portfolio.
  • Eli Lilly's orforglipron is the first oral GLP-1 receptor agonist to complete phase III trials, showing significant weight-loss and blood sugar control results.
  • In a 40-week trial, orforglipron helped type 2 diabetes patients lose an average of 7.9% of their body weight and achieve A1C reductions of 1.3–1.6%.
  • Novo Nordisk's stock price has partially rebounded after falling nearly 10% last week following Lilly's strong trial results.
  • Eli Lilly plans to seek regulatory approval for orforglipron as a weight-loss drug by the end of 2024 and for type 2 diabetes by 2026.