Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has granted approval for an additional use of Wegovy in reducing the risk of severe cardiovascular events, including death, heart attack, or stroke in adults diagnosed with heart disease. This benefit is applicable for those who are obese or overweight who follow a calorie-reduced diet and engage in regular physical activity.
Previously, Wegovy was exclusively prescribed as a medication for adults and children aged 12 and older with obesity or adults with overweight who also have weight-related medical conditions. The drug is designed to aid in weight loss and manage weight effectively when used in combination with a reduced-calorie diet and regular physical activity.
The recent FDA approval is founded on the outcomes of a phase 3 cardiovascular trial that investigated the implications of adding a 2.4 mg dosage of Wegovy or a placebo to the cardiovascular standard of care. This assessment targeted adults with overweight and obesity with confirmed cardiovascular disease and without diabetes. The trial showed that a substantial reduction in risk was associated with the first occurrence of a three-part composite MACE (Major Adverse Cardiovascular Events) endpoint, including cardiovascular death, non-lethal heart attack, or non-lethal stroke, when Wegovy 2.4 mg was administered.
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