FDA clears Wegovy manufacturer to market weight-loss drug for heart health


March 8 (UPI) -- The Food and Drug Administration on Friday approved Wegovy manufacturer Novo Nordisk's application to add cardiovascular benefits to the weight-loss drug's label.

The decision makes Wegovy to first weight-loss drug to be marketed to prevent cardiovascular events such as heart attack or stroke.

"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," Novo Nordisk President Doug Langa said in a statement.

The label expansion is expected to improve insurance coverage for Wegovy -- the sister drug to Novo Nordisk's better-known Ozempic -- which costs more than $1,300 per month out of pocket. Many insurers, including Medicare, don't cover drugs for weight loss.

Dr. Harlan Krumholz, a cardiologist and scientist at Yale University and Yale New Haven Hospital, said the importance of Wegovy is "not about appearance but about health. "

"The evidence is that they reduce risk and save lives -- and so it is indefensible to deny people access, or make it difficult for people to access, medications that will directly improve their health," she said.

The FDA approval is based on a 17,000-patient study that showed people who took Wegovy had a 20% lower risk of a cardiac event than people who took a placebo.

Wegovy is indicated for people who are considered obese -- body mass index of 30 -- or overweight -- BMI of 27 -- and have at least one "weight-related" condition such as high blood pressure or cholesterol.

"This patient population has a higher risk of cardiovascular death, heart attack and stroke," Dr. John Sharretts, director of the FDA's Division of Diabetes, Lipid Disorders and Obesity said in a statement. "Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health."

Approximately 70% of American adults struggle with obesity or being overweight, according to the FDA. These conditions carry an added risk of premature death and cardiovascular health problems.

The Novo Nordisk's trial was done with people who have had cardiac events in the past. More studies need to be done to determine heart benefits for people who have not suffered a cardiac event.

FDA approval may improve insurance coverage for Wegovy, but there continues to be a shortage of the drug as manufacturers struggle to keep up with demand. Novo Nordisk has said it is gradually increasing its supply over the course of this year.

"The shortages are really, really bad right now," Dr. Jody Dushay, an endocrinologist at Beth Israel Deaconess Medical Center and an assistant professor of medicine at Harvard Medical School, told CNN.

Dushay said she's hopeful that the approval would improve insurance coverage, as generic weight-loss drugs come with an increased heart risk, but expanded access could create a demand that manufacturers might not be able to meet.

In a statement, Langa said Novo Nordisk is working "to increase manufacturing capacity to responsibly supply this important medicine."