WASHINGTON (dpa-AFX) - Novo Nordisk (NVO) said that the U.S. Food and Drug Administration has approved an additional indication for Wegovy to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight along with a reduced calorie diet and increased physical activity.
The new indication adds to the prescribing label for Wegovy, a prescription-only medicine previously approved help adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off when used along with a reduced calorie diet and increased physical activity.
The FDA decision was based on the results of the phase 3 cardiovascular outcomes trial that examined the effect of adding Wegovy 2.4 mg or placebo to cardiovascular standard of care in adults with overweight and obesity with established cardiovascular disease and without diabetes. Wegovy 2.4 mg significantly reduced the risk for first occurrence of a three-part composite MACE endpoint consisting of cardiovascular death, non-fatal heart attack, or non-fatal stroke.
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