Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) 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.¹ This new indication adds to the prescribing label for Wegovy^®, a prescription-only medicine previously approved for 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.¹

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“Today, we’re taking a pivotal step forward in addressing some of the most pressing health issues of our time with the added indication for Wegovy^®,” said Doug Langa, Executive Vice President, Head of North America Operations, and President of Novo Nordisk Inc. “We recognize how important this moment is for the millions of people who live with excess weight or obesity and known heart disease, and we will continue to advance options that put their needs first. Reducing this risk is a key part of our commitment to driving change for this community, as we work to increase manufacturing capacity to responsibly supply this important medicine.”

The FDA decision is based on the results of the landmark SELECT 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 CVD and without diabetes.² 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.^1,2 The primary composite outcome occurred in 6.5% of patients treated with Wegovy^® and 8.0% with placebo. The estimated relative risk reduction of MACE was 20% vs placebo (HR 0.80 [95% CI: 0.72, 0.90] p <0.001, absolute risk reduction of 1.5% at 40 months, the mean follow-up duration).^1,2 The reduction of MACE with Wegovy^® was not impacted by age, sex, race, ethnicity, baseline BMI, or level of renal function impairment.^1,2

Safety data collection was limited to serious adverse events (including death), adverse events leading to discontinuation, and adverse events of special interest.^1,2 In the SELECT trial, the proportion of patients for whom serious adverse events were reported was 33.4% in patients randomized to Wegovy^® 2.4 mg and 36.4% of patients receiving placebo.² Sixteen percent (16%) of Wegovy^®-treated patients and 8% of placebo-treated patients, respectively, discontinued study drug due to an adverse event.¹ The most common adverse event leading to discontinuation was gastrointestinal disorders, occurring in 10% of patients in the Wegovy^® group and 2% in the placebo group.²

“This approval is a significant decision because people living with excess weight or obesity and established cardiovascular disease and without diabetes have never had an FDA-approved treatment option that lowers weight and reduces the likelihood of another cardiovascular event,” said Dr. A. Michael Lincoff, Professor of Medicine at Cleveland Clinic and the lead study author of the SELECT outcomes trial. “For healthcare professionals, this approval provides a new treatment option to help us address cardiovascular residual risk that remains for patients on current standard of care.” 

Between 1999 and 2020, obesity-related cardiovascular disease deaths tripled in the U.S., according to the American Heart Association.³ In fact, more than one in three U.S. adults live with obesity,⁴ one of the leading risk factors contributing to heart disease and stroke.⁵