Novo Nordisk Should Have Studied Insulin Icodec Twice-Weekly Dosing, US Panel Says

 
• By Sue Sutter
  
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FDA had recommended studying a twice-weekly dose, but Novo declined because it would add complexity to treatment for type 1 diabetes. However, the firm’s proposed strategy for reducing hypoglycemia risk with once-weekly insulin icodec would create its own complexity, panel said.

Complexity
Novo Nordisk said a twice-weekly insulin icodec regimen would have created too much complexity. • Source: Shutterstock

Novo Nordisk’s decision not to study a twice-weekly dose of insulin icodec because it would add treatment complexity rang hollow to the US Food and Drug Administration’s external experts who said the once-weekly dosing regimen had a negative benefit-risk profile in type 1 diabetes.

Key Takeaways

  • Novo chose not to follow FDA’s recommendation that it add a twice-weekly insulin icodec arm to the pivotal trial in type 1 diabetes.

Contrary to FDA advice, Novo opted not to include a twice-weekly insulin icodec arm in the Phase III trial because...

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