Weight-loss drug approved to cut heart risks in overweight patients
Marking paradigm shift in obesity treatment
LOS ANGELES, March 10, (AP): The popular weight-loss drug Wegovy, which has helped millions of Americans shed pounds, can now be used to reduce the risk of stroke, heart attacks and other serious cardiovascular problems in patients who are overweight or who have obesity, federal regulators said Friday.
The U.S. Food and Drug Administration approved a label change requested by drugmaker Novo Nordisk that expands the use of semaglutide.
The decision was based on the results of a study that found that Wegovy cut the risk of serious heart problems - including heart attack, stroke and heartrelated deaths. Higher-weight patients with heart disease but not diabetes were 20% less likely to experience those problems compared with patients who took placebo, or dummy shots, the study found.
Wegovy is the first medication approved to help prevent the potentially life-threatening events in this population, the agency said.
“Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health,” said Dr. John Sharretts, who directs FDA’s division of diabetes, lipid disorders and obesity.
The move will change the way many heart patients are treated, said Dr. Martha Gulati, a cardiologist at Cedars-Sinai Medical Center in Los Angeles. It confirms that the new class of obesity medications are useful for improving health, not just losing weight.
“The hope is that insurers will start understanding that this is not a vanity drug,” said Gulati, who estimated that nearly 70% of her heart patients could be eligible for treatment.
Wegovy is a higher-dose version of Ozempic, the diabetes treatment that was previously approved to cut the risk of serious heart problems in people with that disease. The weight-loss drug typically costs about $1,300 a month.
Novo Nordisk has also asked European Union regulators to expand the use of the drug for heart problems. EU regulators have not weighed in on the request.
The FDA cautioned that Wegovy carries the risk of serious side effects, including thyroid tumors and certain cancers. Other possible side effects can include low blood sugar; pancreas, gallbladder, kidney or eye problems; and suicidal behavior or thinking.