Obesity drug Wegovy (semaglutide) is approved to cut heart attack and stroke risk in overweight patients
The popular weight-loss drug, 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, the U.S. Food and Drug Administration said.
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 heart-related 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. 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.
About a third of the more than 17,600 participants in the clinical trial reported serious side effects. About 17% in the group that took Wegovy and about 8% of those who received placebo left the study because of those effects.
The new indication could increase coverage of the drug by Medicare, experts said. The federal health insurance program for older Americans is currently barred by law from covering drugs for weight loss alone. The agency spent nearly $3 billion in 2021 covering Ozempic to treat diabetes, according to latest available figures.
March 13, 2024
