Injection pens of Novo Nordisk’s weight-loss drug Wegovy are shown on this photo illustration in Oslo, Norway, Nov. 21, 2023.
Victoria Klesty | Reuters
The Food and Drug Administration on Friday approved Novo Nordisk‘s blockbuster weight reduction drug Wegovy to be used in slashing the danger of significant cardiovascular complications in adults with obesity and heart disease.
Tens of millions of patients already use the favored injectable treatment. However the agency’s decision could widen insurance coverage for the costly drug and similar treatments for obesity, which has been a serious barrier to access for patients.
The approval also demonstrates that weight reduction drugs have significant health advantages beyond shedding unwanted kilos and regulating blood sugar. Weekly injections of Wegovy slashed the general risk of heart attack, stroke and death from cardiovascular causes by 20%, in line with a landmark late-stage trial on the drug.
Wegovy is now the first-ever weight reduction medication to realize an expanded approval for that purpose, Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity within the FDA’s Center for Drug Evaluation and Research, said in a release.
He noted that adults with obesity and heart disease are at increased risk of those cardiovascular complications, so providing a treatment option that’s proven to lower that risk “is a serious advance for public health.”
The FDA said Wegovy patients should use Wegovy along with a reduced calorie food plan and increased physical activity.
Wegovy and its lower-dose diabetes counterpart Ozempic soared in demand and slipped into shortages over the past yr for his or her ability to assist patients lose significant weight over time.
They’re a part of a category of medicine that mimic a hormone produced within the gut called GLP-1 to suppress an individual’s appetite. Each Wegovy and Ozempic cost around $1,000 per thirty days before insurance.
In a press release on Friday, Novo Nordisk said the approval represents a “pivotal step forward in addressing among the most pressing problems with our time.” The corporate added that it’s working to extend manufacturing capability to “responsibly supply this necessary medicine.”
Novo Nordisk expects to receive an analogous Wegovy approval within the EU this yr.
The FDA’s approval was based on a landmark phase three trial called SELECT. The study tested Wegovy in roughly 17,500 individuals with obesity and heart disease but who didn’t have diabetes.Â
Wegovy reduced the danger of non-fatal heart attack by 28% within the five-year trial. It produced a smaller 7% reduction within the occurrence of non-fatal stroke, though few strokes were seen within the trial overall.
Wegovy also began to indicate a discount in overall cardiovascular events inside months after participants began the drug. The difference between the drug and placebo widened because the study continued.
Nearly 17% of individuals receiving Wegovy within the trial stopped taking the drug, mainly due to gastrointestinal issues like vomiting and diarrhea. That is double the speed of people that discontinued the placebo.
One other limitation of the study was its lack of diversity. Almost three-quarters of the participants were male, and much more were white. Nearly 4% of participants were Black.
The brand new data could also help the Danish drugmaker maintain its lead over Eli Lilly, whose competing weight-loss drug Zepbound was approved within the U.S. in November. Zepbound has been shown to assist people lose more weight, however it has yet to exhibit an effect on cardiovascular outcomes.Â
