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Home Novo Nordisk Receives Positive CHMP Opinion for Ozempic (Semaglutide) 2.0 mg Label Extension in the EU for Intensified Type 2 Diabetes Treatment

Novo Nordisk Receives Positive CHMP Opinion for Ozempic (Semaglutide) 2.0 mg Label Extension in the EU for Intensified Type 2 Diabetes Treatment

Nov 14, 2021 02:59 CST Updated 02:59
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.


November 14, 2021 /BioValleyBIOON/ -- Novo Nordisk recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval of the hypoglycemic drugOzempic (Chinese brand name: Nuovotai®, generic name: semaglutide), subcutaneous formulation, once weekly) for label expansion of the existing marketing authorization:Introduction of a New 2.0mg Dosage. Currently, Ozempic is approved in the EU for the treatment of type 2DiabetesAdult patients, with doses of 0.5mg and 1.0mg.

Now, the CHMP opinion will be submitted to the European Commission (EC) for review, which usually makes a final review decision within 2 months. Currently, the Ozempic 2.0mg label extension application is also under review in the United States.FDAThe review. If approved,Ozempic 2.0mg will provide intensified treatment for Type 2 diabetes patients to achieve personalized blood glucose targets.DiabetesPatients are provided with an important treatment option.

The positive review opinion of the CHMP is based on the results of the Phase 3b SUSTAIN FORTE trial. The data shows,Compared with the approved 1.0mg dose of Ozempic, the 2.0mg dose of Ozempic demonstrated statistically significant and superior efficacy in lowering blood glucose (HbA1C).Both doses have shown good safety and tolerability, with the most common adverse events being gastrointestinal events.

Ozempic is a once-weekly glucagon-like peptide-1 (GLP-1) analog, administered as a subcutaneous injection. The currently approved doses are 0.5mg and 1.0mg, and it is indicated for: (1) use as an adjunct to diet and exercise to improve glycemic control in adults with type 2DiabetesGlycemic control in adult patients; (2) For type 2 diabetes with cardiovascular disease (CVD)DiabetesIn adult patients, reduce the risk of major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal heart attack, non-fatal stroke).

SUSTAIN FORTE is a 40-week Phase 3b efficacy and safety trial that enrolled 961 adults with type 2 diabetes requiring intensified treatment (additional glycemic control). The study evaluated once-weekly subcutaneous injections of semaglutide 2.0mg versus semaglutide 1.0mg as an add-on to metformin and/or sulfonylureas. The primary endpoint was the reduction in blood glucose levels (HbA1c) at week 40 of treatment. The data analysis presented at the meeting employed a statistical method based on the trial product estimand, which assesses treatment effects assuming all patients remained on the study drug without initiating other glucose-lowering medications.

The results showed that the trial met the primary endpoint:After 40 weeks of treatment, the 2.0mg dose group showed statistically significant superiority over the 1.0mg dose group in reducing blood glucose levels (HbA1c) (HbA1c reduction from baseline: 2.2% vs 1.9%).. In addition,The 2.0mg dose group also demonstrated superiority in weight loss (6.9 kg vs 6.0 kg).Further post-hoc analysis of the baseline BMI subgroups showed that, compared with the 1.0mg dose, the 2.0mg dose demonstrated a greater reduction in body weight. In the primary analysis, the incidence of adverse events (AEs) was similar for both doses across all baseline HbA1C and BMI subgroups. The most common adverse events were gastrointestinal events (nausea, diarrhea, and vomiting), consistent with the adverse events profile of the GLP-1 receptor agonist class.

SUSTAIN FORTE Trial Results

Semaglutide (司美格鲁肽) is a human glucagon-like peptide-1 (GLP-1) analog that promotes insulin secretion and inhibits glucagon secretion in a glucose concentration-dependent mechanism. It can significantly improve blood glucose levels in patients with type 2 diabetes while posing a low risk of hypoglycemia. Additionally, semaglutide can induce weight loss by reducing appetite and food intake.Weight LossIn addition, semaglutide can significantly reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes.

In China, Novo Nordisk's Ozempic® (1.0mg, 0.5mg) was approved in April 2021 for the treatment of patients with type 2 diabetes (T2D) to improve glycemic control.NovoTai® is a new long-acting glucagon-like peptide-1 (GLP-1) analog with a half-life of up to 7 days, suitable for once-weekly injection with stable blood drug concentration. Combining potent, long-acting, and multi-effective properties, NovoTai® not only effectively helps patients achieve stable blood glucose targets but also provides comprehensive cardiovascular metabolic benefits for long-term patient protection. It significantly improves patient medication adherence, enhances quality of life, and empowers patients to return to a peaceful life.

In China, the number of people with diabetes exceeds 129.8 million, of which only 15.8% have achieved blood glucose control targets. Diabetes easily leads to macrovascular disease, microvascular disease, and other complications, seriously affecting patients' quality of life and increasing their disease burden. Among these, cardiovascular disease is the main cause of death for patients with type 2 diabetes. In China, one in every three diabetes patients also suffers from cardiovascular disease. Poor blood glucose control, along with inadequate management of cardiovascular metabolic indicators such as blood pressure, blood lipids, and weight, are the main reasons for the high incidence of complications among Chinese diabetes patients. Therefore, diabetes treatment needs to focus on comprehensive patient benefits, balancing blood glucose control with cardiovascular outcomes, and managing multiple risk factors comprehensively.

As a once-weekly GLP-1 blockbuster product, NovoTai® employs breakthrough technology to extend its half-life to 7 days, achieving once-weekly dosing, potent blood sugar control, precise target achievement, and comprehensive cardiovascular metabolic benefits. It provides Chinese patients with type 2 diabetes a more effective, convenient, and safer treatment option. The approval of NovoTai® will further drive the transformation of diabetes treatment methods and concepts in China, support comprehensive disease management, improve long-term treatment outcomes, and help patients return to a peaceful life. (Bioon.com)