【Breaking News！】Once a Week! Novo Nordisk’s Ultra-Long-Acting Insulin Approved in China for the Treatment of Diabetes

The National Medical Products Administration (NMPA) of China has announced the approval of the Class 1 new drug Icodec Insulin Injection, submitted by Novo Nordisk, for the treatment of adult type 2 diabetes. This is a new type of basal insulin analog (insulin icodec) designed to meet the weekly basal insulin needs with just one subcutaneous injection per week.

Icodec insulin is a new long-acting insulin analog that can reversibly bind to albumin, forming a reservoir in the circulatory system and releasing slowly and continuously. Within a one-week dosing interval, the blood sugar-lowering effect of icodec insulin is evenly distributed, and the blood sugar-lowering effect can cover a week at clinically relevant doses.

The launch of this product provides a new treatment option for adult patients with type 2 diabetes. Many patients who require insulin treatment often need to inject at least once a day, sometimes even 2-4 times, and may also need to combine with oral medications, which means a complex treatment strategy and difficult self-blood sugar management. Therefore, long-acting insulin is of great significance to diabetic patients.

Icodec insulin was developed by Novo Nordisk’s scientists by modifying the insulin molecule. After injection, the product can firmly and reversibly bind to albumin, forming a “circulatory storage reservoir,” with a half-life of up to 196 hours (about 7 days). This allows icodec insulin to be continuously and stably released, meeting the weekly basal insulin needs of patients. Due to the concentrated formulation, a single injection dose of icodec insulin is equivalent to daily injections of glargine insulin U100 throughout the week.

Icodec insulin is the first innovative achievement of Novo Nordisk to complete clinical trials and submit new drug market applications simultaneously in China, the European Union, and the United States. These applications are based on the results of the ONWARDS clinical research project, which consists of six Phase 3 global clinical trials involving more than 4,000 adult patients with type 1 or type 2 diabetes. All trials have achieved their primary endpoints.

ONWARDS 1 is a 78-week clinical trial for patients with type 2 diabetes who have never used insulin before, comparing the efficacy and safety of weekly injections of icodec insulin and daily injections of glargine insulin U100. The results show that the ability of icodec insulin to reduce glycated hemoglobin (HbA1c) is non-inferior to that of glargine insulin U100.

ONWARDS 2 is a 26-week clinical trial for patients with type 2 diabetes who have used daily insulin injections before, comparing the efficacy and safety of switching to weekly injections of icodec insulin and degludec insulin. The results show that the ability of icodec insulin to reduce HbA1c is non-inferior to degludec insulin and is associated with moderate weight gain.

ONWARDS 3, 4, 5, and 6 are several other clinical trials targeting different patient populations with diabetes, evaluating the comparison of icodec insulin with other insulin treatment plans.

Novo Nordisk stated that icodec insulin can bring potential benefits to patients who need insulin treatment, including helping them transition to a new treatment plan, getting rid of the current cumbersome and complex daily therapy, and potentially providing longer blood sugar control time and reducing the risk of hypoglycemia.