Home Medizin FDA genehmigt Semaglutid zur Reduzierung des kardiovaskulären Risikos

FDA genehmigt Semaglutid zur Reduzierung des kardiovaskulären Risikos

von NFI Redaktion

The US Food and Drug Administration (FDA) has approved the anti-obesity medication Semaglutide 2.4 mg injection (Wegovy) for reducing cardiovascular risk in adults with overweight or obesity and existing cardiovascular diseases.

The label extension now includes the use of the once-weekly glucagon-like peptide-1 receptor agonist (GLP-1) for reducing the risk of major adverse cardiovascular events (MACEs), including cardiovascular death, non-fatal heart attack, or non-fatal stroke. The medication is indicated for use in combination with a reduced-calorie diet and increased physical activity.

„Wegovy is now the first weight loss medication also approved for preventing life-threatening cardiovascular events in adults with cardiovascular diseases 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 has been proven to reduce this cardiovascular risk is a significant advancement for public health,“ he added.

The approval was based on the results of the three-year SELECT study, which randomly assigned 17,604 patients with cardiovascular diseases and a body mass index ≥27 to receive either semaglutide or placebo weekly. None of the patients had diabetes, although two-thirds met the criteria for prediabetes.

The medication reduced the incidence of MACEs by 20% (P <.001). The label will also reflect a 15% risk reduction for cardiovascular deaths and a 19% reduction in deaths of any cause. Additionally, participants lost an average of 9.4% of their body weight in the first two years on semaglutide compared to 0.88% on placebo.

Adverse events leading to treatment discontinuation occurred in 16.6% of the semaglutide group, mainly gastrointestinal effects, and in 8.2% of the placebo group.

The manufacturer of the weight loss medication, Novo Nordisk, has also applied for an extension of the approval in the European Union. A decision is expected in 2024.

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