EU approves Wegovy (semaglutide): 18 percent weight loss at 68 weeks of treatment!

Novo Nordisk's obesity drug Wegovy (semaglutide) 2.4mg subcutaneous injection has been approved in the EU, according to the EU New Drug Approval Database: The drug is a once-daily glucagon-like peptide-1 ( GLP-1) analogs for long-term weight management in obese adult patients. Previously, Wegovy was approved by the US FDA in June 2021 and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in September 2021 for long-term weight management. On the US regulatory front, Novo Nordisk submitted a Priority Review Voucher (PRV) to expedite the review.

Wegovy is specifically indicated for: As an adjunct to a low-calorie diet and intensive exercise, for the treatment of obesity (BMI Greater than or equal to 30kg/m2), or overweight (BMI Greater than or equal to 27kg/m2) with at least one weight-related comorbidity (eg, dysglycemia) , hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) in adult patients.

Notably, Wegovy is the first and only once-weekly GLP-1 receptor agonist approved for weight management in obese patients. The above regulatory approvals of Wegovy are based on the results of the STEP Phase 3a clinical trial program. The project involved more than 4,500 obese or overweight adult patients. In clinical trials of subjects without type 2 diabetes, obese patients treated with Wegovy lost an average of 17-18 percent of their body weight over 68 weeks. Throughout the program, Wegovy was safe and well tolerated, with the most common adverse reactions being gastrointestinal.

Despite their best efforts to lose weight, many obese individuals have difficulty achieving and maintaining weight loss due to physiological responses that favor weight recovery. As a weight loss product with unprecedented weight loss efficacy, the approval of Wegovy marks a new era in the treatment of obesity

Obesity is a chronic disease that requires long-term treatment and is associated with many serious health consequences and reduced life expectancy. Obesity-related complications are numerous, including type 2 diabetes, heart disease, obstructive sleep apnea, chronic kidney disease, nonalcoholic fatty liver disease, and cancer.

Semaglutide is a human glucagon-like peptide-1 (GLP-1) analog that stimulates insulin secretion and inhibits glucagon secretion in a glucose concentration-dependent mechanism, which can significantly improve blood glucose levels in patients with type 2 diabetes, and Low risk of hypoglycemia. In addition, semaglutide was able to induce weight loss by reducing appetite and reducing food intake. In addition, semaglutide was able to significantly reduce the risk of major cardiovascular events (MACE) in patients with type 2 diabetes.

In China, semaglutide was approved by the NMPA in April 2021 for the treatment of patients with type 2 diabetes (T2D) to improve blood sugar control. Novotel® is a novel long-acting glucagon-like peptide-1 (GLP-1) analog with a half-life of up to 7 days, suitable for weekly injection and stable plasma concentration.

In China, there are more than 129.8 million people with diabetes, of which only 15.8 percent have achieved blood sugar control. Diabetes can easily lead to macrovascular disease, microvascular disease and other complications, which seriously affects the quality of life of patients and increases the disease burden of patients. Among them, cardiovascular disease is the leading cause of death in patients with type 2 diabetes. In China, 1 in 3 diabetic patients suffers from cardiovascular disease. Insufficient blood sugar 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 benefit of patients, take into account blood sugar control and cardiovascular outcomes, and comprehensively manage multiple risk factors.

As a heavyweight GLP-1 product that can be administered once a week, semaglutide extends the half-life to 7 days with breakthrough technology, achieving once-a-week dosing, powerful glucose control, precise compliance, and comprehensive cardiovascular metabolic benefits, which is a great benefit for China Type 2 diabetes patients are provided with more effective, simpler and safer treatment options. The approval of Novotel® will further promote the reform of diabetes treatment methods and treatment concepts in China, help comprehensive disease management, improve long-term treatment outcomes, and help patients return to a peaceful life.