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Wegovy is no longer just for weight loss.

The U.S. Food and Drug Administration on Friday approved drug company Novo Nordisk’s application to add cardiovascular benefits to the drug’s label, and also to reduce a person’s risk of heart attack, stroke, or heart-related death. It was the first weight loss drug. You are at increased risk for these conditions.

Expanding the label could improve coverage for Wegovy, which costs more than $1,300 per month out-of-pocket before discounts. Many insurance companies, including Medicare, do not cover weight loss drugs, leaving patients scrambling to buy them.

“There is evidence that it reduces risk and saves lives. Therefore, it is indefensible to deny people access or make it difficult to access medicines that directly improve their health.” said physician and scientist Dr. Harlan Krumholz. Yale University and Yale New Haven Hospital made the announcement Friday. He has no conflicts of interest and has not received any payments from Nordisk or Eli Lilly, which manufactures competing drugs. “Importantly, these drugs focus on health, not appearance. We know that treating obesity can reduce cardiovascular risk, but that may only be part of the benefit. there is.”

The approval follows a study of 17,000 people who showed that people taking Wigovy, a sister drug to the well-known Ozempic, had a 20% lower risk of heart events than those taking a placebo. Based on research involving patients.

Wegovy is indicated for people who have a BMI of at least 30 and are considered obese, or who have a BMI of at least 27 and are considered overweight, and who have at least one “weight-related” health condition such as high blood pressure or cholesterol . . Ozempic is approved for her type 2 diabetes. Both use the active ingredient semaglutide, which is part of a class of drugs known as GLP-1 receptor agonists.

“Wegovy is the first weight-loss drug approved for use in the prevention of life-threatening cardiovascular events in adults with cardiovascular disease who are obese or overweight,” said Dr. One Dr. John Sharetz said: and obesity, said a news release from the agency.

“This patient population is at high risk for cardiovascular death, heart attack and stroke,” he added. “Providing treatment options that are proven to reduce this cardiovascular risk is a major advance for public health.”

Novo Nordisk’s trial is aimed at people with cardiovascular disease, who have had a heart attack or stroke in the past, or who have symptoms of peripheral artery disease, such as clogged arteries in the arms or legs. Ta. More research is needed to show whether there are cardiac benefits for people who haven’t had a cardiac event.

Wegovy, like other GLP-1 drugs, continues to be in short supply as drugmakers struggle to keep up with demand. Novo Nordisk announced last month that it would gradually increase supply over the course of this year.

“The supply shortage is really, really severe right now,” Dr. Jodi Dusha, an endocrinologist at Beth Israel Deaconess Medical Center and an assistant professor at Harvard Medical School, said Friday. She said she has no ties to pharmaceutical companies.

She said she hopes the expanded approval will improve insurance coverage, especially since generic drugs that replace weight-loss drugs can come with cardiac risks, but added, “Even with insurance coverage,” he said, “I have no idea how manufacturing will catch up.” ”

But Dushay added: “this is, [the drugs] Among those most at risk for obesity are those with cardiovascular disease.

Doug Langa, head of Novo Nordisk’s North American operations, said in a news release Friday that the company is working to “increase manufacturing capacity to responsibly supply this important medicine.”