Injection pens for the weight-loss drug Wegovy from Novo Nordisk are shown in this illustration in Oslo, Norway, November 21, 2023.
Victoria Kelsty | Reuters
The Food and Drug Administration approved it on Friday Novo NordiskPopular weight loss drug Wegovy for use in reducing the risk of serious cardiovascular complications in adults with obesity and heart disease.
Millions of patients are already using the popular injectable treatment. But the agency's decision could expand insurance coverage for the expensive drug and similar treatments for obesity, which have been a major barrier to access for patients.
The approval also shows that weight-loss drugs have significant health benefits beyond shedding unwanted weight and regulating blood sugar. Weekly injections of Wegovy cut the overall risk of heart attacks, strokes and death from cardiovascular disease by 20%, according to a late-stage trial of the drug.
Wegovy is now the first weight-loss drug ever to receive expanded approval for this purpose, Dr. John Charets, director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA's Center for Drug Evaluation and Research, said in a statement. .
He noted that adults with obesity and heart disease are at increased risk of developing cardiovascular complications, so providing a treatment option that has been shown to reduce that risk “is a major advance for public health.”
The FDA said Wegovy patients should use Wegovy in addition to following a low-calorie diet and increasing physical activity.
Wegovy and its low-dose diabetes counterpart Ozempic have surged in demand and fallen into shortage over the past year for their ability to help patients lose weight significantly over time.
It is part of a class of drugs that mimic a hormone produced in the intestines called GLP-1 to suppress a person's appetite. Wegovy and Ozempic both cost about $1,000 per month before insurance.
In a statement on Friday, Novo Nordisk said the approval represents “a pivotal step forward in addressing some of the most pressing issues of our time.” The company added that it is working to increase manufacturing capacity “to provide this important medicine responsibly.”
Novo Nordisk expects to receive similar Wegovy approval in the EU this year.
The US Food and Drug Administration (FDA) approval was based on a landmark phase III trial called SELECT. The study tested Wegovy on nearly 17,500 people who had obesity and heart disease but did not have diabetes.
Wegovy reduced the risk of a non-fatal heart attack by 28% in the five-year trial. This resulted in a 7% reduction in the incidence of non-fatal strokes, although fewer strokes were seen in the trial overall.
Wegovy also began showing a reduction in total cardiovascular events within months after participants started taking the drug. The difference between the drug and placebo widened as the study continued.
Nearly 17% of people who received Wegovy in the trial stopped taking the drug, mainly due to gastrointestinal problems such as vomiting and diarrhea. This is twice the rate of people who stopped taking the placebo.
Another limitation of the study is its lack of diversity. Nearly three-quarters of participants were male, and even more were white. Only about 4% of participants were black.
The new data could also help the Danish pharmaceutical company maintain its lead Eli Lilly, whose competing weight-loss drug Zepbound was approved in the United States in November. Zepbound has been shown to help people lose more weight, but it has not yet been proven to affect cardiovascular outcomes.
