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
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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.
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Company said dosing twice, instead of once, a week would have added too much complexity to T1D treatment
Contrary to FDA advice, Novo opted not to include a twice-weekly insulin icodec arm in the Phase III trial because having to administer the basal insulin two times a week
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