The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Wegovy (semaglutide) as a treatment to reduce the risk of major cardiovascular events such as cardiovascular death, heart attack, and stroke in adults with heart disease who are also either obese or overweight.

Novo Nordisk has reported record profits generated from its obesity portfolio in the past few years. The company’s obesity drugs, Wegovy and Saxenda (liraglutide), generated DKr41.5bn ($6.1bn) in global sales last year, as per Novo’s 2023 annual report. Wegovy’s label expansion into cardiovascular disease indication is part of Novo’s business strategy to establish itself in that sector.

The FDA’s approval was based on results from the Phase III SELECT trial (NCT03574597). The study evaluated the effect of Wegovy in addition to the standard of care on the risk of cardiovascular events in 17,604 patients who were either obese or overweight. The study reported a 20% reduction in the relative risk of major cardiovascular events compared to placebo.

The trial's primary composite endpoint consisted of cardiovascular death, nonfatal myocardial infarction, or non-fatal stroke measured in months. The primary composite outcomes occurred in 6.5% of patients on the Wegovy treatment arm, compared to 8% of the participants observing these outcomes in the placebo group.

Approximately 33.4% and 36.4% of the participants reported serious adverse events in the treatment and placebo groups, respectively. The discontinuation rates due to an adverse event were 16% among Wegovy-treated patients and 8% for those on placebo, with the most common adverse event leading to discontinuation being gastrointestinal disorders.

The obesity market is booming, with market leaders such as Novo and Lilly also looking for ways to expand the target populations for these drugs with more labelled indications. Wegovy is expected to generate peak global sales exceeding $17bn in 2027, according to GlobalData’s market analysis.

GlobalData is the parent company of Pharmaceutical Technology.

The companies are also having to continuously expand their manufacturing capacities to keep up with the demand. This growing demand has also led to an influx of counterfeit products. Last month, the FDA sent warning letters to two online retailers, Synthetix and US Chem Labs, for selling unapproved and misbranded versions of GLP-1 therapies semaglutide and tirzepatide. Multiple countries, including the US, Germany and the UK, have seized counterfeit Ozempic, another Novo Nordisk drug that has the same active ingredient as Wegovy and has been used off-label to treat obesity.