Injection pens of Novo Nordisk’s weight loss drug Wegovy are seen in this photo in Oslo, Norway, November 21, 2023.
Victoria Klesty | Reuters
The Food and Drug Administration on Friday approved Novo NordiskWegovy weight loss blockbuster drug for use in reducing the risk the serious ones 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 costly drugs and similar treatments for obesity, which has been a major barrier to patient access.
The approval also proves that weight loss drugs have significant health benefits beyond shedding unwanted pounds and regulating blood sugar. Weekly injections of Wegovy reduced the overall risk of heart attack, stroke and death from cardiovascular causes by 20%, according to a major late-stage trial of the drug.
Wegovy is now the first weight-loss drug to receive expanded approval for this purpose, said Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders and Obesity at the FDA’s Center for Drug Evaluation and Research. .
He noted that adults with obesity and heart disease are at increased risk for these cardiovascular complications, so providing a treatment option that is proven to reduce that risk “is a major public health advance.”
The FDA said Wegovy patients should use Wegovy in addition to a reduced-calorie diet and increased physical activity.
Wegovy and its lower-dose diabetes counterpart Ozempic have soared in demand and fallen into short supply over the past year because of their ability to help patients lose significant weight over time.
They are part of a class of drugs that mimic a hormone produced in the gut called GLP-1 to suppress a person’s appetite. Both Wegovy and Ozempic cost about $1,000 a month before insurance.
In a statement on Friday, Novo Nordisk said the approval represented a “pivotal step forward in addressing some of the most pressing issues of our time.” The company added that it is working to increase production capacity to “responsibly supply this important medicine.”
Novo Nordisk expects to receive similar Wegovy approval in the EU this year.
The FDA approval was based on a phase three landmark trial called SELECT. The study looked at Wegovy in about 17,500 people with obesity and heart disease, but who did not have diabetes.
Wegovy reduced the risk of non-fatal heart attack by 28% in the five-year trial. It produced a smaller 7% reduction in the occurrence of non-fatal stroke, although few strokes were seen in the trial overall.
Wegovy also began to show a reduction in overall cardiovascular events within months of participants starting the drug. The difference between the drug and the placebo widened as the study continued.
Almost 17% of people taking Wegovy in the trial stopped taking the drug, mainly because of gastrointestinal problems such as vomiting and diarrhoea. This is twice the rate of people who discontinued the placebo.
Another limitation of the study was the lack of diversity. Nearly three-quarters of the participants were male, and even more were white. Just 4% of participants were black.
The new data could also help the Danish drugmaker maintain its lead Eli Lilly, whose rival weight-loss drug Zepbound was approved in the US in November. Zepbound has been shown to help people lose more weight, but has yet to show an effect on cardiovascular outcomes.