Weight-loss drug Wegovy can be marketed for heart benefits after FDA label update

By Meg Tirrell, CNN

(CNN) — Wegovy’s not just for weight loss anymore.

The US Food and Drug Administration on Friday approved drugmaker Novo Nordisk’s application to add cardiovascular benefits to the medicine’s label, making it the first weight-loss drug to also be cleared to reduce the risk of heart attack, stroke or heart-related death in people at higher risk of these conditions.

The label expansion may improve insurance coverage for Wegovy, which costs more than $1,300 per month out of pocket before any discounts. Many insurers, including Medicare, don’t cover drugs for weight loss, leaving patients scrambling to afford them.

“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. He has no conflicts of interest and hasn’t received any payments from Novo Nordisk or Eli Lilly, which makes competing medicines. “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 is based on a 17,000-patient study that showed that people taking Wegovy, the sister drug to the better-known Ozempic, had a 20% lower risk of a cardiac event than those taking a placebo.

Wegovy is indicated for people with a body mass index of at least 30 – considered to have obesity – or those with a BMI of at least 27 – considered overweight – and at least one “weight-related” health condition like high blood pressure or cholesterol. Ozempic is approved for type 2 diabetes. Both use the active ingredient semaglutide, part of a class of drugs known as GLP-1 receptor agonists.

“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 from the agency.

“This patient population has a higher risk of cardiovascular death, heart attack and stroke,” he added. “Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”

Novo Nordisk’s trial was done in people with cardiovascular disease, meaning they had a previous heart attack or stroke or symptoms of peripheral artery disease – clogged arteries in the arms or legs. More studies need to be done to show whether there are heart benefits for people who haven’t had a cardiac event.

Wegovy continues to be in shortage, along with other GLP-1 medicines, as drugmakers struggle to keep up with demand. Novo Nordisk said last month that it’s gradually increasing the supply over the 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. She said she has no affiliations with drugmakers.

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

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

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

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