Novo Nordisk's Once-Weekly Fixed-Ratio Combination IcoSema Receives IND Approval in China for Type 2 Diabetes

By Medicine Perspective

China's National Medical Products Administration Center for Drug Evaluation (CDE) recently announced that the 1st class new drug IcoSema injection, submitted by Novo Nordisk, has received tacit approval for clinical trials and is proposed for development to treat diabetes. Public information indicates that IcoSema is a combination of long-acting insulin Icodec and the long-acting GLP-1 analog semaglutide, which is currently undergoing Phase 3 clinical trials globally for Type 2 diabetes.

Screenshot source: CDE official website

Icodec insulin was developed by scientists at Novo Nordisk through modifications to the insulin molecule. After injection, icodec firmly but reversibly binds to albumin, creating a "circulating reservoir" with a half-life of up to 196 hours. This allows the candidate drug to release insulin continuously and steadily, meeting a patient’s basal insulin needs for an entire week. Due to its concentrated formulation, a single dose of icodec is equivalent to daily injections of insulin glargine U100 over a week. The product was approved for clinical trials in China in November 2020 and is intended for the treatment of diabetes.

Semaglutide is a glucagon-like peptide-1 (GLP-1) analog that, through breakthrough optimization of its peptide chain structure, extends the molecule's half-life to 7 days, allowing for once-weekly dosing with very stable blood drug concentrations. In April 2021, the semaglutide injection was approved in China for the treatment of type 2 diabetes. In the United States, the product has also been approved by the FDA to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and established cardiovascular disease, as well as for weight management in individuals with general obesity or overweight. Additionally, the product is currently undergoing a phase 3 international multicenter clinical trial for non-cirrhotic nonalcoholic steatohepatitis (NASH).

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Public information shows that IcoSema is a novel fixed-ratio combination (FRC) product consisting of 350U icodec and 1 mg semaglutide. The product is recommended for once-weekly administration to improve patient adherence and glycemic control outcomes. According to reports, compared with single-component treatments, IcoSema is expected to reduce glycated hemoglobin (HbA1c) more effectively, offers better weight control advantages compared with basal insulin, and is anticipated to reduce the risk of hypoglycemia.

According to the ClinicalTrials website, Novo Nordisk is currently conducting an international multicenter Phase 3 clinical trial named COMBINE 3 to compare the efficacy of once-weekly IcoSema with daily insulin glargine in controlling blood glucose levels in patients with type 2 diabetes.

The approval of IcoSema for clinical trials in China means that the product is also about to undergo clinical trials in the country. It is hoped that IcoSema will achieve more breakthroughs in clinical research and bring more treatment options to diabetes patients as soon as possible.

References:

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Nov. 24, 2021, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2]Kalra, S., Bhattacharya, S. & Kapoor, N. Contemporary Classification of Glucagon-Like Peptide 1 Receptor Agonists (GLP1RAs). Diabetes Ther 12, 2133–2147 (2021). https://doi.org/10.1007/s13300-021-01113-y

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