In a groundbreaking move, the US Food and Drug Administration (FDA) has granted approval for Novo Nordisk’s weight-loss drug, Wegovy, to be marketed with added cardiovascular benefits. This milestone makes Wegovy the first of its kind to not only aid in weight loss but also to reduce the risk of heart attack, stroke, or heart-related death in individuals at higher risk for these conditions.
The FDA’s decision follows an extensive 17,000-patient study showcasing Wegovy’s effectiveness. Participants taking Wegovy, a sibling medication to the well-known Ozempic, exhibited a 20% lower risk of cardiac events compared to those on a placebo.
Wegovy is indicated for individuals with a body mass index (BMI) of at least 30, classified as obese, or those with a BMI of at least 27, considered overweight, along with at least one “weight-related” health condition such as high blood pressure or cholesterol. Both Wegovy and Ozempic share semaglutide as their active ingredient, belonging to the GLP-1 receptor agonists drug class. While Ozempic is approved for type 2 diabetes, Wegovy has now secured approval as the first weight loss medication to prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight.
Dr. John Sharretts, the FDA’s director of the Division of Diabetes, Lipid Disorders, and Obesity, highlighted the significance of this approval, stating, “Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”
Despite this groundbreaking achievement, Wegovy remains in short supply, along with other GLP-1 medicines, as manufacturers strive to meet the surging demand. Novo Nordisk is actively working to enhance manufacturing capacity throughout the year, as announced in a recent statement by Doug Langa, Novo Nordisk’s head of North America Operations.
The expanded FDA approval is anticipated to impact insurance coverage positively, potentially addressing the challenges faced by patients in affording weight-loss medications. However, concerns persist regarding manufacturing catching up with demand, especially with the drug’s widening scope. This development could also lead to prioritized usage among those with the highest-risk obesity, particularly those with concurrent cardiovascular disease, according to Dr. Jody Dushay, an endocrinologist at Beth Israel Deaconess Medical Center.
