US FDA approves Novo Nordisk's Wegovy for lowering heart risks
By Patrick Wingrove and Sriparna Roy
(Reuters) -The U.S. Food and Drug Administration approved Novo Nordisk (NYSE:NVO)'s weight-loss drug Wegovy on Friday for lowering the risk of stroke and heart attack in overweight or obese adults who do not have diabetes.
Novo's widely used diabetes drug Ozempic and weight-loss drug Wegovy, both chemically known as semaglutide, belong to a class of drugs called GLP-1 agonists. Originally developed for type 2 diabetes, they also reduce food cravings and cause the stomach to empty more slowly.
Patients who are obese or overweight are at «a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health,» said John Sharretts, FDA's director of the Division of Diabetes, Lipid Disorders, and Obesity.
Millions of people already take Novo's GLP-1 drugs, but the FDA's stamp of approval for the heart benefits is likely to open their use to more patients.
Dr. Chad Weldy, a cardiologist at Stanford University, said he typically deferred to the primary care team to initiate and monitor therapy with drugs like Wegovy in the past, but said that likely is going to need to change.
«Cardiology groups will need to fully incorporate these therapies into clinic and build a clinical workflow to manage dose escalation, side effects, and insurance approval,» he said.
Healthcare professionals should monitor patients taking the medicine for kidney disease, diabetic retinopathy and depression or suicidal behaviors or thoughts, the FDA said.
The Danish drugmaker published the full data in November from a large clinical trial that showed the obesity drug reduced the risk of non-fatal heart attack
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