Novo Nordisk Submits NDA in China for Once-Weekly Icodec Insulin/Semaglutide Combination Therapy for Type 2 Diabetes

Dec 07, 2024 08:23 CST Updated 08:23

Novo Nordisk

Insulin Developer and Manufacturer

▎WuXi AppTec Content Team Report

Today (December 6), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) showed that Novo Nordisk A/S submittedIcodec Insulin Semaglutide InjectionThe listing application has been accepted. Public information shows that this is a compound product named IcoSema developed by Novo Nordisk. At the investor meeting in the first half of this year, Novo Nordisk announced positive results of IcoSema in the pivotal Phase 3 trial COMBINE 1 and stated that it plans to submit this therapy to regulatory authorities in China, the United States, and the European Union in the second half of this year.Marketing Application for the Treatment of Type 2 Diabetes (T2D) Patients. It can be inferred that,The indication for which IcoSema has applied for marketing approval in China is for the treatment ofType 2 Diabetes.

Screenshot source: CDE official website

IcoSema isA fixed-ratio combination of once-weekly insulin icodec and once-weekly semaglutide。Icodec insulin is a human insulin analog with three amino acid substitutions and an attached C20 eicosanedioic acid chain, allowing the molecule to reversibly bind to albumin, thereby extending its half-life to 196 hours (approximately 7 days), reaching a steady state after 3-4 weekly injections.The therapy is designed for once-weekly subcutaneous injection.Icodec insulin has been approved in the EU, Canada, Australia, and Japan, and also in China this June.Approved for Marketing。Semaglutide is a glucagon-like peptide-1 (GLP-1) analog, which, through breakthrough optimization of its peptide chain structure, extends the molecular half-life to 7 days, allowing for once-weekly dosing with very stable blood drug concentration.

In June this year, Novo Nordisk announced positive results for IcoSema in the pivotal Phase 3 trial COMBINE 1. The COMBINE 1 trial is an international Phase 3 trial designed to compare the blood glucose control effects of once-weekly IcoSema with once-weekly insulin Icodec in patients with type 2 diabetes.A total of 1291 patients were enrolled in the trial and randomly assigned to receive IcoSema orIcodec InsulinTreatment lasted for 52 weeks, followed by a 5-week follow-up period.

Analysis shows,The trial met its primary endpoint, with HbA1c levels in the IcoSema group decreasing by 1.6 percentage points from baseline at week 52, compared to a 0.9 percentage point reduction in the insulin icodec group.Point, the difference is statistically significant.As for the secondary endpoints,Patients in the IcoSema group lost 3.7 kilograms at 52 weeks, while those in the insulin icodec group gained 1.9 kilograms.`, the difference between the two groups was statistically significant.`

▲COMBINE 1 Trial Design and Results (Image Source: Reference [2])

In addition,The probability of severe hypoglycemic events in the IcoSema group (0.14 events per patient per year) was also significantly lower than that in patients treated with insulin icodec (0.63 events per patient per year).。IcoSema Demonstrates Good Safety and Tolerability in Trials.

IcoSema has three late-stage studies for the development of type 2 diabetes. In addition to COMBINE 1, Novo Nordisk announced positive results from COMBINE 3 earlier this year.Phase 3a Clinical TrialData, the results show,In 679 patients with type 2 diabetes who had poor glycemic control on once-daily basal insulin, once-weekly IcoSema demonstrated non-inferiority in lowering HbA1c compared to once-daily insulin therapy.

According to the official website of China's Drug Clinical Trial and Information Disclosure Platform, Novo Nordisk has completedCompletion of a Phase 1 Clinical Study on IcoSema Injection for Patients with Type 2 DiabetesThat is, the characteristics of icodec insulin and semaglutide when administered alone or simultaneously in Chinese subjects with type 2 diabetes.

References:

[1]Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Dec 7, 2024, fromhttps://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2]Novo Nordisk – a focused healthcare company. Retrieved August 12, 2024 from https://cdn.ipaper.io/iPaper/Files/d486663f-a195-49e2-b8ee-443a0d235bc6.pdf?Policy=eyJTdGF0ZW1lbnQiOlt7IlJlc291cmNlIjoiaHR0cHM6Ly9jZG4uaXBhcGVyLmlvL2lQYXBlci9GaWxlcy8qIiwiQ29uZGl0aW9uIjp7IkRhdGVMZXNzVGhhbiI6eyJBV1M6RXBvY2hUaW1lIjoxNzU0OTg2OTIxfX19XX0_&Signature=M6V4924Oo3vrU6mzHvAKurhKN0yttg4LvpOBJNUOlHit4jsH3XY-f0cnlPktIKS9WFDJnJYZ8N3WnH5bDeZvpd2eU~5PQOraACYcd7ZmivuQDEaYUyPRWzQdpRZqra5qqUrqh1~jUS6zxTkXkoQArA7lxjV5oMggLDLFXV~FcxI_&Key-Pair-Id=APKAIPGQN6BDBMBZ2LCA

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