- Novo Nordisk’s Wegovy can list heart-related benefits on its label, the FDA said.
- In a clinical trial, the drug was shown to reduce the risk of cardiovascular events such as heart attack and stroke.
- The FDA’s new approval applies to people who are living with obesity or overweight and also have cardiovascular disease.
Novo Nordisk’s weight loss drug Wegovy received the go-ahead from the Food and Drug Administration to list heart-related benefits on its label, the first in its class with this expanded offering.
Injectable Wegovy (semaglutide) is now approved to reduce the risk of death due to heart attack, stroke, and death from cardiovascular disease. This new use is intended for people who are living with obesity or overweight and also have cardiovascular disease.
The drug is meant to be used in addition to a reduced-calorie diet and increased physical activity.
“This patient population has a higher risk of cardiovascular death, heart attack, and stroke,” said Dr. John Sharretts, FDA Center for Drug Evaluation and Research’s head of diabetes, lipid disorders, and obesity, in the agency’s
The FDA
The FDA based its approval on Novo Nordisk’s SELECT trial, which enrolled 17,604 adults ages 45 years or older who were living with obesity or overweight, and had cardiovascular disease but no history of diabetes.
After 5 years, treatment with Wegovy reduced the risk of cardiovascular events by 20% compared to an inactive placebo, Novo Nordisk said in its press release.
These outcomes included death from cardiovascular disease and non-fatal heart attack or stroke.
Patients in both groups received standard-of-care blood pressure and cholesterol management, as well as healthy lifestyle counseling such as diet and physical activity.
Treatment with Wegovy also reduced the risk of death from cardiovascular disease by 15% and death from any cause by 19%, both compared to placebo, according to the company’s release.
Dr. Beverly Tchang, endocrinologist and Ro obesity medicine advisor, said the FDA’s approval of Wegovy for the prevention of heart disease suggests this family of drugs is better thought of as a “metabolic corrector” rather than a weight-loss drug.
“They’re not just for obesity,” she told Healthline. “They’re for obesity and diabetes and now heart disease, and probably for metabolic dysfunction-associated liver disease (MASLD) next.”
Novo Nordisk’s Ozempic was approved by the FDA in 2017 for lowering blood sugar in people with type 2 diabetes, to be used alongside a healthy diet and regular physical activity.
Semaglutide, the active ingredient in Ozempic and Wegovy, is a GLP-1 agonist. It mimics the action of the hormone GLP-1, which is made in the small intestine.
This hormone is involved in triggering the release of insulin from the pancreas after eating, slowing the emptying of the stomach and increasing how full you feel after eating.
Since the approval of Ozempic and Wegovy, clinical trials have explored the potential benefits of semaglutide beyond blood sugar control and weight loss.
Recent
Elina Onitskansky, founder and CEO of Ilant Health, said the new study “reinforces that obesity treatment is about improving health, not addressing size.”
“To get the most value from care,” she told Healthline, “it’s important that consumers and employers work with providers and solutions that are focused on metabolic health improvement, not just ‘weight loss.’”
The FDA approval of Wegovy for reducing the risk of cardiovascular disease may lead to more insurers covering this medication for people at risk of heart-related problems.
“I hope this increases access for consumers because it forces payers to recognize the indisputable value of this medication,” said Tchang. “Anti-obesity medications are poorly covered by insurance, but perhaps insurers will take Wegovy seriously now that it’s also a heart medication.”
Given the heart-related benefits of Wegovy, Tchang said some cardiologists have compared the drug to cholesterol-lowering statins, which can prevent heart attacks and strokes in people at risk of cardiovascular disease.
However, “in the SELECT trial, the cardiovascular benefit [of Wegovy] was clear early on, before significant weight loss,” she said.
“[This] means we’re not treating a disease that leads to heart disease — as we do with [high blood lipids] or [high blood pressure] — we’re treating cardiovascular disease directly, as we do with aspirin,” she said.
The FDA approved Novo Nordisk’s Wegovy (semaglutide) for reducing the risk of heart attack, stroke, and death from cardiovascular disease. The new use is intended for people who are living with obesity or overweight and also have cardiovascular disease.
A clinical trial found that over five years, injectable Wegovy reduced the risk of cardiovascular events such as heart attack and stroke by 20% compared to people who received an inactive placebo.
Semaglutide was initially approved by the FDA as Novo Nordisk’s Ozempic to lower blood sugar in people with type 2 diabetes, and later as Wegovy for chronic weight management.
Clinical trials are exploring other benefits of this and similar drugs.