Injection pens of Novo Nordisk’s weight-loss drug Wegovy are proven on this picture illustration in Oslo, Norway, Nov. 21, 2023.
Victoria Klesty | Reuters
The Meals and Drug Administration on Friday accepted Novo Nordisk‘s blockbuster weight reduction drug Wegovy to be used in slashing the danger of significant cardiovascular issues in adults with weight problems and coronary heart illness.
Tens of millions of sufferers already use the favored injectable remedy. However the company’s resolution might widen insurance coverage protection for the expensive drug and related therapies for weight problems, which has been a significant barrier to entry for sufferers.
The approval additionally demonstrates that weight reduction medicine have vital well being advantages past shedding undesirable kilos and regulating blood sugar. Weekly injections of Wegovy slashed the general danger of coronary heart assault, stroke and loss of life from cardiovascular causes by 20%, in keeping with a landmark late-stage trial on the drug.
Wegovy is now the first-ever weight reduction treatment to achieve an expanded approval for that objective, Dr. John Sharretts, director of the Division of Diabetes, Lipid Issues, and Weight problems within the FDA’s Middle for Drug Analysis and Analysis, stated in a launch.
He famous that adults with weight problems and coronary heart illness are at elevated danger of these cardiovascular issues, so offering a remedy choice that’s confirmed to decrease that danger “is a significant advance for public well being.”
The FDA stated Wegovy sufferers ought to use Wegovy along with a lowered calorie weight loss plan and elevated bodily exercise.
Wegovy and its lower-dose diabetes counterpart Ozempic soared in demand and slipped into shortages over the previous 12 months for his or her means to assist sufferers lose vital weight over time.
They’re a part of a category of medicine that mimic a hormone produced within the intestine referred to as GLP-1 to suppress an individual’s urge for food. Each Wegovy and Ozempic price round $1,000 per thirty days earlier than insurance coverage.
In a press release on Friday, Novo Nordisk stated the approval represents a “pivotal step ahead in addressing a number of the most urgent problems with our time.” The corporate added that it’s working to extend manufacturing capability to “responsibly provide this vital medication.”
Novo Nordisk expects to obtain an analogous Wegovy approval within the EU this 12 months.
The FDA’s approval was primarily based on a landmark part three trial referred to as SELECT. The examine examined Wegovy in roughly 17,500 folks with weight problems and coronary heart illness however who didn’t have diabetes.
Wegovy lowered the danger of non-fatal coronary heart assault by 28% within the five-year trial. It produced a smaller 7% discount within the prevalence of non-fatal stroke, although few strokes have been seen within the trial total.
Wegovy additionally began to indicate a discount in total cardiovascular occasions inside months after contributors began the drug. The distinction between the drug and placebo widened because the examine continued.
Almost 17% of individuals receiving Wegovy within the trial stopped taking the drug, primarily due to gastrointestinal points like vomiting and diarrhea. That is double the speed of people that discontinued the placebo.
One other limitation of the examine was its lack of variety. Nearly three-quarters of the contributors have been male, and much more have been white. Nearly 4% of contributors have been Black.
The brand new knowledge might additionally assist the Danish drugmaker preserve its lead over Eli Lilly, whose competing weight-loss drug Zepbound was accepted within the U.S. in November. Zepbound has been proven to assist folks lose extra weight, nevertheless it has but to exhibit an impact on cardiovascular outcomes.
