wegovy

US FDA Approves Weight-Loss Drug Wegovy To Be Marketed For Heart Health Benefits 

The US Food and Drug Administration (FDA) approved an application from drugmaker Novo Nordisk that allows the weight loss drug Wegovy to add cardiovascular benefits to the medicine’s label, according to CNN

This marks the first weight-loss drug to be marketed to reduce the risk of heart attack, stroke, or heart-related deaths in people who are at higher risk for cardiovascular issues and/or events. 

The addition to the label may improve some insurance coverage for Wegovy; the “sister drug” to Ozempic. The drug currently costs around $1,300 per month out of pocket, and many insurers don’t cover weight loss drugs. 

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“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,” Dr. Harlan Krumholz, a cardiologist and scientist at Yale University and Yale New Haven Hospital, said Friday

“The point is that these drugs are not about appearance but about health. By treating obesity, we know we can reduce cardiovascular risk, and that may be only a part of the benefits that accrue.”

The approval occurred after a study involving 17,000 patients. The study, according to reports, showed that the patients who took Wegovy had a 20% lower risk of having a cardiac event than those who took the placebo. 

Wegovy is meant to be used for individuals who are considered to be obese or overweight, meaning they have a body mass index of anything between 27 – 30, as well as have a weight-related health condition such as high blood pressure or high cholesterol. 

“Wegovy is now the first weight loss medication to also be approved to help 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, said in a news release.

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“This patient population has 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.”

The trial performed prior to this classification was done with patients with cardiovascular disease. They’ve either previously had a heart attack, stroke, or symptoms of peripheral artery disease: which is when one has clogged arteries in their arms or legs. 

Wegovy, however, has and is in a shortage currently, and drugmakers are struggling to keep up with the demand. Novo Nordisk released a statement last month that stated it would be gradually increasing the supply over this 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, said Friday. 

“[I hoped] the expanded approval would improve insurance coverage, particularly as generic weight-loss drug alternatives can carry heart risks, but if insurance comes on board with this indication, [I have] no idea how manufacturing will ever catch up,” she said. 

Dushay added, “this might also help prioritize use of [the drugs] among those with highest-risk obesity, those who also have cardiovascular disease.”