Novo’s Insulin Icodec Hypoglycemia Risk Outweighs Limited Benefit In Type 1 Diabetes

Novo’s Insulin Icodec Hypoglycemia Risk Outweighs Limited Benefit In Type 1 Diabetes–FDA Panel

27 May 2024

The Endocrinologic and Metabolic Drugs Advisory Committee majority says new studies should validate the proposed risk mitigation measures before approval for T1D.

Scales — The risks of insulin icodec outweigh its benefits in type 1 diabetes, the adcomm said. • Source: Shutterstock

Novo Nordisk A/S should conduct more studies before its long-acting insulin icodec can be approved for use in type 1 diabetics, a majority of US Food and Drug Administration advisory committee members said on 24 May.

Seven of 11 members of the Endocrinologic and Metabolic Drugs Advisory Committee said the company failed to demonstrate that the...