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Novo Nordisk recently announced that it has resubmitted a label extension application to the U.
Food and Drug Administration (FDA) for the hypoglycemic drug Ozempic (Chinese trade name: Novo Nordisk®, generic name: semaglutide).
, Smeglutide, subcutaneous preparation, once a week), the introduction of a new dose of 2.
Ozempic is a once-a-week glucagon-like peptide 1 (GLP-1) analogue.
The drug is a subcutaneous injection preparation.
5mg and 1.
0mg doses have been approved in the United States for: (1) As an auxiliary means of diet adjustment and exercise to improve the blood sugar control of adult patients with type 2 diabetes; (2) For adult patients with type 2 diabetes with cardiovascular disease (CVD), reduce the occurrence of major adverse cardiovascular events (MACE, including The risk of cardiovascular death, non-fatal heart attack, non-fatal stroke).
In China, Novotel® (Ozempic, 1.
5mg) was approved in April 2021 for the treatment of patients with type 2 diabetes (T2D) to improve blood sugar control.
Novotel® is a new long-acting glucagon-like peptide-1 (GLP-1) analog with a half-life of up to 7 days.
It is suitable for weekly injection with stable blood concentration.
Novotel®, which is both powerful, long-acting and multi-acting, will not only effectively help patients to achieve stable blood glucose standards, but also help patients achieve long-term protection with comprehensive cardiovascular metabolic benefits, greatly improve patient compliance with medications, and improve patient survival Quality helps patients return to life in peace.
In January 2021, Novo Nordisk submitted a semaglutide 2.
0mg label extension application to the FDA, but received a rejection notice (RFL) from the FDA in March of this year.
In the RFL, the FDA asked Novo Nordisk to provide more information, including data related to the proposed new production site.
In an announcement issued at the time, Novo Nordisk stated that the company believes that the completed clinical trial project is sufficient to support the label extension application of semaglutide 2.
0mg, and it expects to resubmit the application to the FDA in the second quarter of 2021.
The semaglutide 2.
0mg label extension application is based on the results of the SUSTAIN FORTE trial in the SUSTAIN clinical project.
This is a 40-week phase 3b efficacy and safety trial.
A total of 961 adult patients with type 2 diabetes who require intensive treatment were enrolled.
It evaluated weekly subcutaneous injections of semaglutide 2.
0mg and semaglutide 1.
0mg as metformin and/ Or supplementation of sulfonylureas.
The primary end point is the reduction in blood glucose levels (HbA1c) at the 40th week of treatment.
Two statistical methods were used in the trial: (1) Based on treatment policy estimand, which means that all patients adhere to the study drug treatment and do not use other antidiabetic drugs for the treatment effect; (2) Based on the treatment policy Evaluation (treatment policy estimand), that is, regardless of treatment compliance, regardless of whether other antidiabetic drugs are initiated.
SUSTAIN FORTE test data
The results of the test were announced in November 2020.
The data showed that the test reached the primary endpoint: using two evaluation methods, at the 40th week of treatment, the 2.
0 mg dose group blood glucose level (HbA1c) reduction was statistically significantly better than 1.
0 mg Dose group.
In addition, the 2.
0 mg dose group also showed superiority in weight loss.
In this trial, both doses of semaglutide were shown to be safe and well tolerated.
The most common adverse events were gastrointestinal events, most of which were mild to moderate and disappeared over time, consistent with the category of GLP-1 receptor agonists.
Compared with the 1.
0 mg dose of semaglutide, the gastrointestinal adverse events of the 2.
0 mg dose of semaglutide showed similarity.
Semaglutide is a human glucagon-like peptide-1 (GLP-1) analogue, which promotes insulin secretion and inhibits glucagon secretion through a glucose concentration-dependent mechanism, which can make type 2 diabetes mellitus The patient's blood glucose level has improved significantly and the risk of hypoglycemia is low.
In addition, semaglutide can also induce weight loss by reducing appetite and reducing food intake.
In addition, semaglutide can also significantly reduce the risk of major cardiovascular events (MACE) in patients with type 2 diabetes.
In China, the number of diabetic patients exceeds 129.
8 million, of which only 15.
8% have achieved blood sugar control standards.
Diabetes is prone to cause macrovascular disease, microvascular disease and other complications, which seriously affects the quality of life of patients and increases the burden of disease.
Among them, cardiovascular disease is the main cause of death in patients with type 2 diabetes.
In China, 1 in 3 diabetic patients suffers from cardiovascular disease.
Substandard blood glucose control and poor management of cardiovascular and metabolic indicators such as blood pressure, blood lipids, and body weight are the main reasons for the high incidence of complications in Chinese diabetic patients.
Therefore, diabetes treatment needs to focus on the overall benefits of patients, take into account blood glucose control and cardiovascular outcomes, and comprehensively manage multiple risk factors.
As a blockbuster GLP-1 product administered once a week, Novotel® uses breakthrough technology to extend the half-life to 7 days, achieve once a week dosing, powerfully control sugar, accurately meet standards, and benefit from comprehensive cardiovascular metabolism.
, To provide more effective, simple and safe treatment options for Chinese patients with type 2 diabetes.
The approval of Novotel® will further promote the transformation of China's diabetes treatment methods and treatment concepts, help comprehensive disease management, improve long-term treatment outcomes, and help patients return to a peaceful life.
Original source: Novo Nordisk resubmits once-weekly semaglutide 2.
0 mg for the treatment of type 2 diabetes for US regulatory approval
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