Considering the positive data, Novo Nordisk is planning to file for Wegovy’s label expansion in both the US and the European Union (EU) in 2023. Image Credit: Maurice NORBERT / Shutterstock.

Denmark-based Novo Nordisk has announced results from a Phase III cardiovascular clinical trial, where its lead obesity drug Wegovy (2.4mg subcutaneous semaglutide) showed a 20% reduction in cardiovascular events compared to placebo.

The Phase III SELECT trial (NCT03574597) enrolled 17,604 adult patients with cardiovascular disease who were either obese or overweight. The trial evaluated the drug’s impact on preventing major adverse cardiovascular events (MACE) through a composite outcome that looked at death due to a cardiovascular event, a non-fatal myocardial infarction, or a non-fatal stroke, over five years. The study met this primary endpoint, and detailed results are planned for presentation at a medical conference in 2023, as per the company’s press release.

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Novo Nordisk is now planning to file for Wegovy’s label expansion in both the US and the European Union (EU) in 2023.

Wegovy is the subcutaneous formulation of semaglutide, which is a glucagon-like peptide-1 receptor agonist (GLP-1RA) developed to treat type 2 diabetes. Wegovy has been approved in the US and Europe for weight loss management in patients aged 12 years and older.

GlobalData has forecasted the obesity drug market to value at $37.1bn by 2031, with Wegovy being the top-selling drug. Novo Nordisk increased their predicted sales outlook for 2023 in April in light of increased Wegovy sales, to expected growth of 24%–30%.

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However, concerns have been raised by various regulatory bodies such as the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), regarding the increased risk of suicidal thoughts and self-harm with GLP-1RAs such as Wegovy. The EMA has started a review of these drugs, which is expected to complete in November 2023.

Novo Nordisk recently reported a 15.1% reduction in weight with its once-daily oral semaglutide, compared to a 2.4% weight reduction achieved with a placebo.