Injection pens of Novo Nordisk’s weight loss drug Wegovy are seen in this photo illustration in Oslo, Norway, on November 21, 2023.
Victoria Klesty | Reuters
The Food and Drug Administration gave approval Friday Novo NordiskWegovy, the blockbuster weight loss drug, is designed to reduce the risk of serious cardiovascular complications in adults with obesity and heart disease.
Millions of patients are already using the popular injection treatment. But the agency’s decision could expand insurance coverage for the costly cases Anti-obesity medications and similar treatments that have posed a major barrier to access for patients.
The approval also shows that weight loss medications have significant health benefits beyond shedding unwanted pounds and regulating blood sugar. Weekly Wegovy injections reduced the overall risk of heart attack, stroke and death from cardiovascular causes by 20%, according to a landmark late-stage study 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 in the FDA’s Center for Drug Evaluation and Research, in a press release.
He noted that adults with obesity and heart disease are at increased risk of these cardiovascular complications. Therefore, providing a treatment option that has been proven to reduce this risk is “a major advance in public health.”
The FDA said Wegovy patients should take Wegovy in addition to a reduced-calorie diet and increased physical activity.
Demand for Wegovy and its lower-dose diabetes counterpart Ozempic surged last year, facing shortages due to their ability to help patients lose significant weight over time.
They belong to 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 around $1,000 per month before insurance.
In a statement on Friday, Novo Nordisk said the approval represents a “decisive 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 deliver this important medicine.”
Novo Nordisk expects to receive similar Wegovy approval in the EU this year.
The FDA’s approval was based on a groundbreaking Phase 3 study called SELECT. The study tested Wegovy on about 17,500 people with obesity and heart disease but who did not have diabetes.
Wegovy reduced the risk of a non-fatal heart attack by 28% in the five-year trial. It resulted in a smaller 7% reduction in the incidence of non-fatal strokes, although only a few strokes were observed overall in the study.
Wegovy also showed a reduction in overall cardiovascular events within a few months of participants starting taking the drug. The difference between the drug and the placebo increased over the course of the study.
Nearly 17% of people who received Wegovy in the study stopped taking the drug, mostly because of gastrointestinal problems such as vomiting and diarrhea. This is twice as high as in people who stopped taking the placebo.
Another limitation of the study was its lack of diversity. Almost three-quarters of the participants were male, and even more were white. Almost 4% of participants were black.
The new data could also help the Danish drugmaker maintain its lead Eli Lilly, whose competing weight loss drug Zepbound was approved in the US in November. Zepbound has been shown to help people lose more weight, but an effect on cardiovascular outcomes has not yet been demonstrated.
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2024-03-08 20:51:18
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