The U.S. Food and Drug Administration on Friday approved Novo Nordisk’s weight-loss drug Wegovy for use in lowering the risk of stroke and heart attack in overweight or obese adults.
Patients who are 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, the FDA’s director of the Division of Diabetes, Lipid Disorders, and Obesity.
The drug’s maker released results from a 17,604-patient trial which showed the difference in heart protective benefits began to appear almost immediately after starting treatment in those who received Wegovy, researchers said. The study suggested that the cardio benefits were due to more than the weight loss the drug spurs.
The data, published in November, showed the obesity drug reduced the risk of non-fatal heart attack by 28%, non-fatal stroke by 7% and heart-related death by 15%, compared with a placebo, in patients with pre-existing heart conditions.
Wegovy is the first therapy approved in the United States to help people manage their weight and reduce heart disease risk, according to Novo Nordisk. The FDA approval includes people who are overweight but do not have diabetes, Reuters reported.
Wegovy has the same active ingredient found in the diabetes drug Ozempic, which is often prescribed off-label for weight loss. Both drugs are manufactured by Novo Nordisk.
While millions take the drug for diabetes and weight loss, the FDA’s approval for use in heart patients is likely to make it available to millions more.
Heart disease is the leading cause of death in the United States, according to the Centers for Disease Control and Prevention.
Whether the approval will lead to insurance companies being more like to cover its cost is not clear.
Wegovy (semaglutide) has a list price of about $1,350 for a 28-day supply. This means that the medication could cost more than $16,000 per year without insurance or manufacturer discounts.
Coverage for the drug varies depending on the type of insurance you have.
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