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Wegovy (Semaglutide 2.4 mg): A New Era in Obesity Treatment with Significant and Sustained Weight Loss Over Two Years

Nov 07, 2021 10:22 CST Updated 10:22
Novo Nordisk

Insulin Developer and Manufacturer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

European Medicines Agency

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.

European Commission

The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.


November 07, 2021 /BioonBIOON/ -- Novo Nordisk recently announced at the ObesityWeek® 2021 conferenceNew obesity drug Wegovy (semaglutide, 2.4 mg subcutaneous injection)a Phase 3bClinical TrialResults of (STEP 5). This trial was conducted in 304 adult patients with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) to evaluate the efficacy and safety of Wegovy versus placebo for the treatment of obesity or overweight, both in combination with a reduced-calorie diet and increased physical activity, over a treatment period of 104 weeks (2 years). Data showed:Adult Patients Treated with Wegovy Achieved Significant and Sustained Weight Loss Over a 2-Year Study Period。

Specifically,Compared with the placebo group, patients in the Wegovy treatment group experienced significantly greater weight loss from baseline to Week 104 (-15.2% vs -2.6%; treatment difference: -12.6% [95% CI: -15.3, -9.8]; p < 0.0001).. Furthermore, the study also demonstrated that, compared with the placebo group, the Wegovy treatment groupA significantly higher proportion of patients achieved weight loss ≥5% (77.1% vs 34.4%; p < 0.0001).. Based on multiple previous 68-week trials, the most commonly reported adverse events associated with Wegovy were nausea, diarrhea, vomiting, constipation, and abdominal pain. In the STEP 5 trial, the safety profile of Wegovy was consistent with that of the previous STEP 3a trial; 5.9% of patients in the Wegovy treatment group and 4.6% in the placebo group permanently discontinued treatment due to adverse events.

Dr. W. Timothy Garvey, Professor and Chair of the Department of Nutritional Sciences at the University of Alabama at Birmingham, stated: “Patients with obesity attempt an average of 7 times before seeking medical careWeight Loss。However, once weight is lost, it often rebounds, which is why finding interventions that can help patients with obesityWeight Loss...and the reasons why it is crucial to find ways to prevent obesity and maintain weight loss. The results of the STEP 5 trial demonstrate that adults with obesity treated with Wegovy over a two-year period were able to achieve and sustain weight loss. This helps us better treat and manage obesity as a chronic disease.”

Novo Nordisk President and Executive Vice President, North America Operations Doug Langa said: "Obesity is a chronic disease associated with at least 60 other health conditions and reduced life expectancy.。The approval of Wegovy gives us an important opportunity to drive meaningful change in obesity treatment.”

Obesity is a chronic disease requiring long-term treatment, and it is associated with numerous serious health consequences and reduced life expectancy. There are many obesity-related complications, including type 2Diabetes mellitus, heart disease, obstructive sleep apnea, chronic kidney disease, non-alcoholic fatty liver disease, and cancer.

In June this year, the United States,FDAApproval of Wegovy (semaglutide, 2.4 mg subcutaneous injection),This drug is a once-weekly glucagon-like peptide-1 (GLP-1) analog for long-term weight management., this medication is specifically indicated for: as an adjunct to a reduced-calorie diet and increased physical activity, for the treatment of adult patients with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. From a regulatory perspective, Novo Nordisk submitted a Priority Review Voucher (PRV) to expedite the review.

It is worth mentioning that,Wegovy is the first and only once-weekly GLP-1 receptor agonist approved for weight management in patients with obesity.This approval is based on the results of the STEP 3a clinical trial program. The program involved over 4,500 adult patients with obesity or overweight. In patients without type 2Diabetes mellitusconducted in subjects withClinical Trialin,Patients with obesity treated with Wegovy experienced an average weight loss of 17–18% over 68 weeks.Throughout the program, Wegovy was safe and well-tolerated, with the most commonAdverse ReactionsIt is a gastrointestinal adverse reaction.

In the United States, the regulatory approval of Wegovy has brought significant hope to individuals with obesity. Despite best efforts# Weight Loss, but due to physiological responses that favor weight regain, many individuals with obesity still struggle to achieve and maintain weight loss.As aWeight lossA weight-loss medication with unprecedented efficacy, Wegovy marks a new era in the treatment of obesity.

Semaglutide (Semaglutide) is a human glucagon-like peptide-1 (GLP-1) analog that promotes insulin secretion and inhibits glucagon secretion via a glucose concentration-dependent mechanism, which can improve type 2Diabetes mellitusPatients' blood glucose levels showed significant improvement, with a lower risk of hypoglycemia. Additionally, semaglutide can induce weight loss by reducing appetite and decreasing food intake. Furthermore, semaglutide can also significantly reduce type 2Diabetes mellitusRisk of major adverse cardiovascular events (MACE) in patients.

In China,Ozempic® (English trade name: Ozempic, semaglutide, semaglutide injection, former provisional name: somarutide)was approved by the National Medical Products Administration (NMPA) in April this year,For the treatment of patients with type 2 diabetes (T2D) to improve glycemic control。Ozempic® is a novel long-acting glucagon-like peptide-1 (GLP-1) analogue with a half-life of up to 7 days, suitable for once-weekly injection and maintaining stable plasma drug concentrations.

In China, the number of patients with diabetes exceeds 129.8 million, with only 15.8% achieving target glycemic control. Diabetes predisposes patients to macrovascular and microvascular complications, as well as other comorbidities, severely impairing quality of life and increasing the disease burden. Among these, cardiovascular disease is the leading cause of mortality in patients with type 2 diabetes. In China, one in every three patients with diabetes is affected by cardiovascular disease. Suboptimal glycemic control, coupled with inadequate management of cardiometabolic risk factors such as blood pressure, blood lipids, and body weight, is the primary driver of the high complication rates among Chinese patients with diabetes. Therefore, diabetes management should focus on comprehensive patient benefits, balancing glycemic control with cardiovascular outcomes, and implementing integrated management of multiple risk factors.

As a blockbuster once-weekly GLP-1 product, Nuohetai® leverages breakthrough technology to extend its half-life to 7 days, enabling once-weekly administration. It delivers potent glycemic control, precise target attainment, and comprehensive cardiovascular and metabolic benefits, offering patients with type 2 diabetes in China a more effective, convenient, and safe therapeutic option. The approval of Nuohetai® will further drive the transformation of diabetes treatment modalities and therapeutic paradigms in China, support comprehensive disease management, improve long-term clinical outcomes, and help patients return to a life of well-being. (Bioon.com)