Wegovy It is no longer indicated just for weight loss. The United States regulatory agency, FDA (Food and Drug Administration) approved, on Friday (8), the request from pharmaceutical company Novo Nordisk to add cardiovascular benefits to the medicine label .
With this, it became the first weight loss drug to also be released for reduce the risk of heart attack stroke, or heart-related death in people are at greater risk for these conditions.
The brand expansion could improve insurance coverage for Wegovy, which costs more than $1,300 a month before any discounts. Many American insurers, including Medicare, do not cover weight-loss medications, leaving patients struggling 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 them to access, medicines that will directly improve their health,” says Harlan Krumholz, a cardiologist and scientist at Yale University. It's from Yale New Haven Hospital. The specialist has no conflicts of interest and has not received any payments from Novo Nordisk or Eli Lilly, which makes competing drugs.
“The point is that these drugs are not about appearance, they are about health. By treating obesity, we know that we can reduce cardiovascular risk, and this may be just part of the resulting benefits”, he adds.
Approval is based on a study with 17,000 patients that showed that people taking Wegovy, the sister drug to the better-known Ozempic, had a 20% lower risk of suffering a cardiac event than those taking a placebo.
Wegovy is indicated for people with a BMI (body mass index) of at least 30 – considered obese – or those with a BMI of at least 27 – considered overweight – and at least one “weight-related” health problem, such as blood pressure high or cholesterol.
Ozempic is approved for type 2 diabetes. Both use the active ingredient semaglutide, part of a class of medications known as GLP-1 receptor agonists.
“Wegovy is now the first weight loss drug to be approved to also help prevent life-threatening cardiovascular events in adults with cardiovascular disease and obesity or overweight,” says John Sharretts, director of the FDA's Division of Diabetes and Lipid Disorders, and obesity, in statement to the press carried out by the agency.
“This patient population is at increased risk of cardiovascular death, heart attack and stroke,” he added. “Providing a treatment option that is proven to reduce cardiovascular risk is a major advance for public health.”
Novo Nordisk's trial was carried out in people with cardiovascular disease, meaning they had a previous heart attack or stroke or symptoms of peripheral arterial disease – blocked arteries in the arms or legs. More studies need to be done to show whether there are cardiovascular benefits for people who have not had a cardiac event.
Wegovy remains in short supply, along with other GLP-1 drugs, as drugmakers struggle to keep up with demand. Novo Nordisk said last month it is gradually increasing supply throughout this year.
“The shortage is really, really bad right now,” Jody Dushay, an endocrinologist at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School, said Friday. She claims to have no affiliations with pharmaceutical companies.
The expert says she hopes the expanded approval will improve insurance coverage, especially since generic weight-loss drug alternatives can carry heart risks, but noted that “if insurance comes up with this indication,” she “has no idea how manufacturing will follow [a demanda].”
But, Dushay added, “it can also help prioritize the use [dos medicamentos] among those with higher risk obesity” who also have cardiovascular disease.
Novo Nordisk's head of operations in North America, Doug Langa, says, in Press releasethat the company is working “to increase production capacity to responsibly supply this important medicine.”
Source: CNN Brasil

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