Once-weekly semaglutide 2.4 mg injection (Wegovy, Novo Nordisk) has been granted a positive opinion in the European Union for weight management in people with obesity or those who are overweight with one or more weight-related conditions.
The specific indication is for chronic weight management in adults with obesity (initial body mass index ≥ 30 kg/m2) or overweight (initial BMI ≥ 27 kg/m2) with at least one weight-related comorbidity such as high blood pressure, heart disease, or type 2 diabetes.
The November 11 decision by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) follows approval of the once-weekly glucagon-like peptide-1 (GLP-1) agonist formulation for weight loss by the UK Medicines and Healthcare Products Regulatory Agency in September 2021 and the US Food and Drug Administration (FDA) in June 2021. The European launch is planned for the second half of 2022.
In the United States, the availability of the once-weekly 2.4-mg injectable semaglutide for weight management was deemed "likely to usher in a new era in the medical treatment of obesity," according to one speaker at the virtual American Diabetes Association 81st Scientific Sessions in June. Others have called it a "game changer."
The positive CHMP opinion for Wegovy was based on data from the Semaglutide Treatment Effect in People With Obesity (STEP) clinical trial program, involving 4500 people with obesity or overweight but without type 2 diabetes.
Those who received Wegovy achieved a weight loss of 17%-18%, sustained over 68 weeks, which some have said is comparable to weight loss achieved with bariatric surgery. The most common adverse events were gastrointestinal in nature.
Label Extension for Higher Dose to Treat Type 2 Diabetes
Prior to these approvals for weight management, lower-dose injectable formulations of semaglutide, of 0.5 mg and 1.0 mg (Ozempic, Novo Nordisk), were approved in Europe and the United States for the treatment of type 2 diabetes.
On November 12, the EMA CHMP also issued a positive opinion for a label extension to include a 2.0-mg formulation of Ozempic for the treatment of type 2 diabetes, according to Novo Nordisk.
The endorsement of the label extension for type 2 diabetes treatment was based on data from the SUSTAIN FORTE trial, in which people with type 2 diabetes who received once-weekly semaglutide 2.0 mg achieved a significantly greater reduction in A1c compared to semaglutide 1.0 mg at 40 weeks. Again, gastrointestinal discomfort was the most common adverse event.
Final approval of Ozempic 2.0 mg by the European Commission is expected in approximately 2 months, and it will be launched in the EU in the first half of 2022. The label expansion for the 2.0-mg dose is still under review by the FDA.
Other Formulations, Compounds for Weight Loss and Diabetes Impress
An oral formulation of semaglutide (Rybelsus, Novo Nordisk) for the treatment of type 2 diabetes has been approved in the United States since September 2019 and in the EU since January 2020.
But Novo Nordisk isn't the only player in the type 2 diabetes/weight loss space.
Eli Lilly's investigational twincretin tirzepatide, an injectable dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist, was found to be superior to 1-mg semaglutide in reducing A1c and weight loss in 1900 randomized patients with type 2 diabetes in a pivotal head-to-head trial.
Adjectives used for those results have included "impressive" and "stunning."
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR's Shots blog, and Diabetes Forecast magazine. She is on Twitter: @MiriamETucker.
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Lead Image: Novo Nordisk
Cite this: Europe Gives Green Light to Once-Weekly Semaglutide for Weight Loss - Medscape - Nov 16, 2021.