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FDA Approves Semaglutide for Cardiovascular Risk Reduction
The US Food and Drug Administration (FDA) has approved the anti-obesity drug semaglutide 2.4 mg injection (Wegovy) for reducing cardiovascular risk in adults with overweight or obesity and established cardiovascular disease.
The label expansion now includes use of the once-weekly glucagon-like peptide 1 (GLP-1) agonist for reducing risks for major adverse cardiovascular events (MACEs) including cardiovascular death, nonfatal heart attack, or nonfatal stroke. The drug is indicated for use in combination with a reduced calorie diet and increased physical activity.
"Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight," said John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research, in an FDA statement.
"This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health," he added.
The approval was based on results from the 3-year SELECT trial, which randomly assigned 17,604 patients with cardiovascular disease and body mass index ≥ 27 to weekly semaglutide or placebo. None of the patients had diabetes, although two thirds met prediabetes criteria.
The incidence of MACEs was reduced by 20% with the drug (P <.001). The label will also reflect the risk reduction of 15% for cardiovascular death and 19% for death from any cause. Participants also lost a mean of 9.4% of body weight over the first 2 years with semaglutide vs 0.88% with placebo.
Adverse events leading to discontinuation of treatment occurred in 16.6% in the semaglutide group, mostly gastrointestinal effects, and in 8.2% in the placebo group.
The makers of the weight loss medication, Novo Nordisk, has also filed for a label expansion in the European Union, with a decision expected in 2024.
