This photo illustration shows an injection pen for Novo Nordisk’s weight loss drug Wegovy, taken on November 21, 2023, in Oslo, Norway.
Victoria Cresty | Reuters
The U.S. Food and Drug Administration approved it Friday Novo NordiskBlockbuster weight loss drug Wegovy is used for Reduce risk serious cardiovascular complications Adults with obesity and heart disease.
Millions of patients already use the popular injectable treatment.But the agency’s decision could expand expensive coverage Medications and similar obesity treatments have been a major barrier to patient access.
The approval also shows that the weight-loss drug has significant health benefits beyond losing excess weight and regulating blood sugar. Weekly injections of Wegovy could reduce the overall risk of heart attack, stroke and death from cardiovascular causes by 20 percent, according to a landmark late-stage trial of the drug.
Wegovy is now the first weight-loss drug to receive expanded approval for this purpose, John Sharretts, Ph.D., director of the division of diabetes, dyslipidemia and obesity in the FDA’s Center for Drug Evaluation and Research, said in a press release.
He noted that adults with obesity and heart disease are at increased risk of cardiovascular complications, so providing a treatment option proven to reduce risk “is a major public health advance.”
The FDA says patients with Wegovy should use Wegovy in addition to a reduced-calorie diet and increased physical activity.
Wegovy and its low-dose diabetes drug Ozempic have experienced surges in demand but have run into shortages over the past year because of their ability to help patients significantly lose weight over time.
They are part of a class of drugs that suppress appetite in humans by mimicking a hormone called GLP-1 produced in the gut. Insurance costs for Wegovy and Ozempic are approximately $1,000 per month.
Novo Nordisk said in a statement on Friday that the approval represents “a critical step forward in solving some of the most pressing issues of our time.” The company added that it was working to increase production capacity to “responsibly supply this important medicine.”
Novo Nordisk expects to receive similar approval for Wegovy in the European Union this year.
The FDA approval was based on a landmark Phase 3 trial called SELECT. The study tested Wegovy on about 17,500 people with obesity and heart disease but without diabetes.
In a five-year trial, Wegovy reduced the risk of non-fatal heart attacks by 28%. Although there were few strokes throughout the trial, it reduced the incidence of non-fatal strokes by 7%.
Wegovy also began to show a reduction in overall cardiovascular events within months of participants starting taking the drug. As the study continued, the differences between the drug and placebo widened.
In trials, nearly 17% of patients treated with Wegovy stopped taking the drug, mostly because of gastrointestinal problems such as vomiting and diarrhea. That’s double the rate among people who stopped taking the placebo.
Another limitation of the study is the lack of diversity. Almost three-quarters of the participants were male, and even more were white. Only about 4% of participants were black.
New data could also help the Danish drugmaker stay ahead of the curve Eli Lilly and CompanyIts 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 been shown to have an impact on cardiovascular outcomes.
About The Author
