This image provided by Novo Nordisk in January 2023, shows packaging for the company's Wegovy medication. The popular weight-loss drug, which has helped millions of Americans shed pounds, can now be used to reduce the risk of stroke, heart attacks and other serious cardiovascular problems in patients who are overweight or who have obesity, the U.S. Food and Drug Administration said Friday, March 8, 2024. (Novo Nordisk via AP)
The FDA announced on Friday that Wegovy, a popular weight-loss medication known for its effectiveness in helping Americans lose weight, has received approval for a label change. This change permits the drug to be used for reducing the risk of stroke, heart attacks, and other serious cardiovascular issues in overweight or obese patients.
The label modification, requested by Novo Nordisk, the drug manufacturer, expands the use of semaglutide, the active ingredient in Wegovy. The decision was influenced by a study revealing that Wegovy significantly lowered the risk of severe heart problems, including heart attacks, strokes, and heart-related deaths. Particularly, patients with higher weights and heart disease but without diabetes were found to be 20% less likely to experience these issues compared to those who received a placebo.
Dr. John Sharretts, who heads the FDA's division of diabetes, lipid disorders, and obesity, emphasized the significance of providing a treatment option that effectively reduces cardiovascular risk, considering it a major advancement for public health.
Dr. Martha Gulati, a cardiologist at Cedars-Sinai Medical Center, highlighted the transformative impact this decision will have on the treatment of heart patients, suggesting that it underscores the utility of new obesity medications in improving health beyond weight loss alone.
Wegovy, a higher-dose version of Ozempic, a diabetes treatment, typically costs around $1,300 per month. Novo Nordisk has also sought approval from EU regulators to expand the drug's usage for heart problems.
However, the FDA cautioned about potential serious side effects associated with Wegovy, including thyroid tumors, certain cancers, low blood sugar, and various organ problems. About one-third of participants in the clinical trial reported serious side effects, leading to concerns about safety.
The new indication for Wegovy could potentially expand its coverage by Medicare, although this may depend on insurers' evaluation of the drug's effectiveness and cost. Novo Nordisk is addressing supply shortages, which have persisted for over a year, hindering broader access to the medication.
Dr. Gulati emphasized the urgency of wider access to Wegovy, stressing the importance of reducing costs and ensuring availability for patients in need.
