The FDA has approved a label change for the weight-loss drug Wegovy, allowing it to be used to reduce the risk of stroke, heart attacks, and other serious cardiovascular problems in patients who are overweight or have obesity. This decision follows a study that showed Wegovy significantly decreased the risk of heart-related issues, including heart attack, stroke, and heart-related deaths.
The study found that higher-weight patients with heart disease but without diabetes were 20% less likely to experience these problems when taking Wegovy compared to those who received a placebo. This makes Wegovy the first medication approved to prevent such events in this population.
Dr. John Sharretts, from the FDA, stated that providing a treatment option proven to lower cardiovascular risk is a significant advancement for public health. Dr. Martha Gulati, a cardiologist, noted that this approval will change the way many heart patients are treated and emphasizes the health benefits of the new class of obesity medications.
Wegovy, a higher-dose version of Ozempic, typically costs around $1,300 a month. While the drug has shown promising results, it also carries risks of serious side effects, including thyroid tumors, certain cancers, low blood sugar, and other health issues.
The FDA cautioned that about a third of participants in the clinical trial reported serious side effects, with some discontinuing the study due to these effects. Despite the potential benefits, limited drug supply has been a challenge, with Novo Nordisk working to increase production.
The new indication for Wegovy could lead to increased coverage by Medicare, potentially allowing more individuals to access the drug. Private insurers will also evaluate coverage decisions based on the FDA's approval.
While drugmakers and obesity advocates have been advocating for expanded coverage, concerns remain about the cost-effectiveness of these medications and their impact on healthcare spending related to obesity and heart disease.
Overall, the approval of Wegovy for reducing cardiovascular risk in overweight patients marks a significant development in the treatment of obesity-related health issues, with potential implications for public health and insurance coverage.
