The world's first weekly insulin preparation has encountered setbacks in its launch in the United States.
On July 10, Denmark time, Novo Nordisk announced that it had received a complete response letter (CRL) from the United States Food and Drug Administration (FDA), which covered the application for biological product licensing (BLA) for the treatment of adult diabetes with insulin, a weekly preparation of basic insulin (English name: Insulin icodec).
On June 24 of this year, insulin injection (Chinese trade name: Novosi) was officially approved for marketing in China to treat adult type 2 diabetes. novo nordisk
Novo Nordisk said that the US FDA requires it to provide detailed information about the production process and the indications for type 1 diabetes. Novo Nordisk is evaluating the relevant content and working closely with the US FDA to meet the requirements, but it is expected that these requirements will not be met this year.
With regard to the setback of Iko insulin in the United States, Novo Nordisk responded to Time Finance and said: "Novo Nordisk will continue to be committed to fulfilling its commitment to patients with diabetes, and will cooperate with the US FDA to solve possible problems and determine the follow-up steps required to complete the approval."
The half-life of Yike insulin is as long as 196 hours (about 7 days), which means that within a one week dosing interval, the hypoglycemic effect of this product is evenly distributed. At clinically relevant doses, the hypoglycemic effect time can cover one week.
In April 2023, Novo Nordisk submitted a marketing application for Ecoinsulin to the US FDA. In May of this year, the Endocrine and Metabolic Medicine Advisory Committee of the US FDA held a meeting, where an independent scientific expert group discussed the specific situation of Yike insulin. At this meeting, the US FDA believed that the existing data could not support the use of this drug in patients with type 1 diabetes.
Novo Nordisk told Time Finance that the relevant suggestions discussed above are only about the treatment of type 1 diabetes. The FDA did not seek the opinions of the committee on the use of Eko insulin in adult type 2 diabetes at this meeting.
Although the approval of Yike insulin in the United States has encountered setbacks, this product has already been approved in multiple regions around the world, including the European Union, Switzerland, Canada, and Australia.
In March 2024, the Commission for Human Medicines (CHMP) of the European Drug Administration approved the use of Eko insulin injection (European listed brand name: Awiqli) for the treatment of adult diabetes. CHMP believes that this product achieves better blood glucose reduction effect and better blood glucose range retention time in patients with type 2 diabetes compared with daily basic insulin.
In terms of the Chinese market, on June 24 of this year, Iacovin injection (Chinese trade name: Novosi) was officially approved for listing in China for the treatment of adult type 2 diabetes, but the specific time and price of commercialization were not announced yet.
The tenth version of the IDF diabetes map shows that the total number of adult diabetes patients in China has reached 140 million, ranking first in the world. Among them, type 2 diabetes patients account for the majority, but only 16.5% of Chinese adult diabetes patients reach the standard of blood glucose control. Insulin is the best choice for most patients with diabetes. However, in the use of insulin, patients often have low compliance. Many patients are unwilling to take injections or inject drugs many times a day. Therefore, the approval of long-acting insulin is more convenient for patients.
Novo Nordisk's old rival, Eli Lilly, is also laying out insulin weekly preparations. In May of this year, Eli Lilly disclosed the research progress of its insulin weekly preparation Efsitora. According to data from two Phase 3 clinical trials, QWINT-2 and QWINT-4, Efsitora showed a comparable reduction in HbA1c (glycated hemoglobin) compared to the most commonly used daily basal insulin globally.
Efsitora is a weekly injection of basal insulin, a fusion protein that combines a novel single chain insulin variant with a human IgG2 Fc domain. It is designed for subcutaneous administration once a week, with a low peak to valley ratio, which may provide more stable blood glucose levels (less blood glucose fluctuations) within a week. Efstora is in the phase 3 development stage for adult type 1 and type 2 diabetes patients.
In terms of domestic pharmaceutical companies, Ganli Pharmaceutical (603087. SH) launched a phase II clinical trial of its self-developed product GZR4 in China in September last year, and completed the first subject administration. This product is a weekly super long acting insulin preparation that is injected subcutaneously once a week, and its indication is diabetes.
At the end of June this year, Ganli Pharmaceutical announced the latest progress of this product at the 84th Scientific Conference of the American diabetes Association (ADA) in 2024. Ganli Pharmaceutical stated that compared with Yike Insulin Injection, GZR4 has a significantly increased affinity for human serum albumin (HSA) and a significantly decreased affinity for insulin receptors. After binding with albumin to form a complex, GZR4 can still maintain the activity of activating insulin receptors. In the study of animal models of diabetes, the hypoglycemic effect of GZR4 is 2-3 times as much as that of Yike insulin injection.