Novo Nordisk Submits Global Regulatory Applications for Once-Weekly Insulin Icodec in Type 1 and Type 2 Diabetes

On May 4, Novo Nordisk announced in its Q1 2023 financial report that it had submitted the marketing application for icodec to treat type 1 and type 2 diabetes in the United States, the European Union, and China in April this year.

This marketing application is primarily based on the positive results from six Phase III ONWARDS studies.

• ONWARDS 1 Study (NCT04460885): Icodec's ability to reduce HbA1c in insulin-naïve patients with type 2 diabetes is non-inferior to insulin glargine U100 (-1.55% vs -1.35%).

• ONWARDS 2 Study (NCT04770532): Icodec’s ability to reduce HbA1c in patients with type 2 diabetes is non-inferior to that of insulin degludec (-0.93% vs -0.71%), and the incidence of hypoglycemic events between the two groups showed no statistically significant difference.

• ONWARDS 3 Study (NCT04795531): Icodec's ability to reduce HbA1c in insulin-naïve patients with type 2 diabetes is non-inferior to degludec (-1.57% vs -1.36%), and there is no statistically significant difference in the incidence of severe hypoglycemia or clinically significant hypoglycemia events between the two groups.

• ONWARDS 4 Study (NCT04880850): Icodec + Insulin Aspart is Non-Inferior to Glargine U100 + Insulin Aspart in Lowering HbA1c in Patients with Type 2 Diabetes (-1.18% vs -1.16%).

• ONWARDS 5 Study (NCT04795531): Icodec’s ability to reduce HbA1c in insulin-naïve patients with type 2 diabetes is non-inferior to basal insulin (-1.68% vs -1.31%), and there is no statistically significant difference in the incidence of severe hypoglycemia or clinically significant hypoglycemia between the two groups.

• ONWARDS 6 Study (NCT04848480): Icodec + Insulin Aspart is Non-Inferior to Degludec + Insulin Aspart in Lowering HbA1c in Patients with Type 1 Diabetes (-0.47% vs -0.51%).

Icodec is an ultra-long-acting insulin formulation designed by Novo Nordisk based on the oral insulin OI338, with a half-life of up to 196 hours in the human body. Its core design involves: ① replacing the 18C long-chain fatty acid with a 20C long-chain fatty acid to enhance the molecule's binding affinity to human serum albumin; ② substituting Tyr (tyrosine) at position 16 of the B chain with His (histidine) to reduce the molecule's affinity for the human insulin receptor.

In addition to single-drug icodec and icodec + insulin, Novo Nordisk has also developed an icodec + semaglutide combination therapy (see: ).

The updates and iterations of insulin products and GLP-1 drugs are the two "key weapons" for Novo Nordisk to maintain its leading position in the diabetes market. As the fastest-progressing weekly insulin formulation worldwide, if icodec gains approval, it will bring about another revolution in diabetes treatment.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably quote. When quoting, please clearly indicate the source of the article; if you need to reprint, please leave a message to the WeChat Official Account backend or send a message, and indicate the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Wonderful Live Broadcast

CUBE LIVE

↑ Click to scan the QR code and reserve a live broadcast ↑

PharmaCube Reader Survey Questionnaire

Thank you for your companionship. Looking forward to your feedback.

Scan the QR code to provide valuable suggestions