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Novo’s Insulin Icodec: Hypoglycemia Events In Type 1 Diabetics Put Broad Indication At Risk

22 May 2024

A US FDA advisory committee will consider whether the benefits of once-weekly insulin icodec outweigh the significantly higher rate of hypoglycemic episodes in patients with type 1 disease. The agency appears satisfied with safety and efficacy in type 2 diabetics.

Continuous glucose monitor — Novo Nordisk proposes to restrict use in type 1 diabetics to those who wear a continuous glucose monitoring device. • Source: Shutterstock

A broad indication for Novo Nordisk A/S’s once-weekly insulin icodec will be at issue when a US Food and Drug Administration advisory committee meets on 24 May to discuss an increased risk of hypoglycemia in patients with type 1 diabetes.

The Endocrinologic and Metabolic Drugs Advisory Committee will consider the risk of hypoglycemia with insulin icodec and proposed mitigation measures,...