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- According to the FDA, Novo Nordisk’s Wegoby can list heart-related benefits on its label.
- In clinical trials, this drug was shown to reduce the risk of cardiovascular events such as heart attack and stroke.
- The new FDA approval applies to people who are obese or overweight and have cardiovascular disease.
Novo Nordisk’s weight loss drug Wegoby has received permission from the Food and Drug Administration to list heart-related benefits on its label. This is a first in class for this expanded offering.
Wegovy injection (semaglutide) is currently approved to reduce the risk of heart attack, stroke, and death from cardiovascular disease. This new use targets people who live obese or overweight and also have cardiovascular disease.
This drug is intended to be used in addition to a reduced calorie diet and increased physical activity.
“This patient population is at increased risk for cardiovascular death, heart attack, and stroke,” Dr. John Sharetz, director of diabetes, dyslipidemia, and obesity in the FDA’s Center for Drug Evaluation and Research, said in the FDA report.
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The FDA based its approval on Novo Nordisk’s SELECT study. The study enrolled 17,604 adults aged 45 and older who lived with obesity or overweight and had cardiovascular disease but no history of diabetes.
Novo Nordisk said in a press release that after five years, treatment with Wegovy reduced the risk of cardiovascular events by 20% compared to an inactive placebo.
These outcomes include death from cardiovascular disease and non-fatal heart attack or stroke.
Patients in both groups received standard blood pressure and cholesterol management, as well as healthy lifestyle counseling such as diet and exercise.
Treatment with Wegovy reduced the risk of death from cardiovascular disease by 15% and the risk of death from any cause by 19% compared to placebo, according to a company release.
Dr. Beverly Chan, an endocrinologist and Ro’s Obesity Medicine Consultant, said the FDA’s approval of Wegovy for the prevention of heart disease means this class of drugs is better thought of as “metabolic correctors” rather than weight loss drugs. He said that it suggests.
“They’re not just targeted at obesity,” she told Healthline. “Obesity and diabetes, now heart disease, and probably metabolic dysfunction-associated liver disease (MASLD) next.”
Novo Nordisk’s Ozempic is effective in lowering blood sugar levels in people with type 2 diabetes and was approved by the FDA in 2017 for use in conjunction with a healthy diet and regular physical activity.
Semaglutide, the active ingredient in Ozempic and Wegovy, is a GLP-1 agonist. It mimics the effects of the hormone GLP-1, which is produced in the small intestine.
This hormone is involved in triggering the release of insulin from the pancreas after a meal, slowing stomach emptying and increasing the feeling of fullness after a meal.
Since the approval of Ozempic and Wegovy, clinical trials have investigated the potential benefits of semaglutide beyond glycemic control and weight loss.
Recent
Elina Onitzkansky, founder and CEO of Ilanto Health, said the new study shows that “obesity treatment is not about size, but about improving health. This confirms that.”
“To get the most value from care, it’s important for consumers and employers to collaborate with health care providers and solutions that focus on improving metabolic health, not just ‘weight loss,'” she said. told Line.
The FDA’s approval of Wegovy to reduce the risk of cardiovascular disease may mean more insurance companies will cover the drug for people at risk for heart-related problems.
“We hope this will increase consumer access because it will make payers aware of the undisputed value of this drug,” Chan said. “Anti-obesity drugs are not often covered by insurance, but perhaps insurance companies will take Wegoby seriously because it is also a heart drug.”
Given Wigovy’s heart-related benefits, Chan said some cardiologists are comparing the drug to cholesterol-lowering statins, which can prevent heart attacks and strokes in people at risk for cardiovascular disease. Ta.
However, “in the SELECT trial, the cardiovascular effects were [of Wegovy] It was clear early on before I lost a lot of weight,” she said.
“[This] This means it is not treating the disease that leads to heart disease. [high blood lipids] or [high blood pressure] “We treat cardiovascular disease directly, just like aspirin,” she said.
The FDA has approved Novo Nordisk’s Wegovy (semaglutide) to reduce the risk of heart attack, stroke, and death from cardiovascular disease. This new use targets people who live obese or overweight and also have cardiovascular disease.
A clinical trial found that over a five-year period, the Wegovy injection reduced the risk of cardiovascular events such as heart attacks and strokes by 20% compared to people who received an inactive placebo.
Semaglutide was originally approved by the FDA as Novo Nordisk’s Ozempic to lower blood sugar levels in people with type 2 diabetes, and later as Wigovy for chronic weight management.
Clinical trials are investigating other benefits of this drug and similar drugs.
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