FDA approves Novo Nordisk’s Wegovy for cardiovascular risk reduction in adults with obesity

The U.S. Food and Drug Administration (FDA) has recently granted an additional indication for Novo Nordisk‘s Wegovy, a milestone in medical advancements aimed at combating cardiovascular diseases (CVD). This new approval positions Wegovy as the first treatment option specifically approved to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease who are either obese or overweight. This significant decision underscores the medication’s dual benefits in addressing obesity and its related cardiovascular risks when coupled with a reduced calorie diet and increased physical activity.

Novo Nordisk Inc.’s Executive Vice President, Doug Langa, emphasized the importance of this approval for millions grappling with excess weight or obesity alongside known heart disease. “Today, we’re taking a pivotal step forward in addressing some of the most pressing health issues of our time,” Langa stated, highlighting the company’s commitment to expanding access to this crucial medicine while increasing manufacturing capacity responsibly.

The FDA’s approval is grounded in the outcomes of the SELECT phase 3 cardiovascular outcomes trial, a pivotal study that explored the impact of adding Wegovy® 2.4 mg to standard cardiovascular care in adults with obesity or overweight and established CVD, but without diabetes. The trial demonstrated that Wegovy significantly reduced the risk of a composite endpoint of cardiovascular death, non-fatal heart attack, or non-fatal stroke by 20% compared to placebo, marking a significant advancement in managing cardiovascular risk factors for this patient group.

In terms of safety, the SELECT trial reported that serious adverse events were slightly lower in the Wegovy-treated group compared to placebo. The most common adverse event leading to discontinuation of the drug was gastrointestinal disorders, emphasizing the importance of monitoring and managing side effects in treatment plans.

Dr. A. Michael Lincoff, Professor of Medicine at Cleveland Clinic and lead study author of the SELECT outcomes trial, lauded the FDA’s approval as a critical advancement for individuals with obesity or overweight and established cardiovascular disease, providing a new treatment paradigm to mitigate cardiovascular risks effectively.

With obesity-related cardiovascular disease deaths tripling in the U.S. from 1999 to 2020, the American Heart Association highlights the urgent need for effective treatment options. Wegovy’s approval marks a significant stride in addressing this growing health crisis, offering hope and a new treatment avenue for millions at risk.