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The U.S. Food and Drug Administration (FDA) on Friday approved the first weight-loss drug for use in reducing the risk of life-threatening cardiovascular events in overweight or obese adults.
Pharmaceutical company Novo Nordisk announced it has updated the label for its weight-loss drug Wegoby and received FDA approval for its use to reduce patients’ risk of heart attack, stroke and cardiovascular death.
Wegovy contains semaglutide, which belongs to a class of drugs called GLP-1 agonists. The drug has so far only been approved to treat obesity and diabetes.
FDA approval is based on a double-blind study involving more than 17,600 participants, which found Wegovy significantly reduced the risk of cardiovascular events by 20 percent compared to a placebo. did.
The study was a large, double-blind, placebo-controlled study aimed at evaluating the cardiovascular effects of this drug in overweight and obese patients without diabetes but with pre-existing heart disease. there were.
Results showed that cardiovascular event risk reduction was achieved over 5 years, regardless of baseline age, sex, race, ethnicity, BMI, or level of renal impairment.
Martin Horst Lange, executive vice president and head of development at Novo Nordisk, said the FDA approval is an “important milestone” for people living with obesity and cardiovascular disease.
“We are thrilled that Wegovy has been approved in the United States as the first treatment to help people manage weight and reduce cardiovascular risk,” Lange said in a press release.
Novo Nordisk has also applied to expand its label in Europe and is hoping for results this year.
Heart disease is one of the leading causes of death worldwide
According to the World Health Organization (WHO), cardiovascular disease is the leading cause of death worldwide, claiming an estimated 17.9 million lives each year.
The WHO said more than four in five cardiovascular-related deaths are due to heart attack or stroke, and one third of these deaths occur in people under 70.
John Sharetz, director of the FDA’s Division of Diabetes, Dyslipidemia, and Obesity, said patients who are overweight or obese are “at increased risk for cardiovascular death, heart attack, and stroke.”
“Providing treatment options proven to reduce this cardiovascular risk is a major step forward for public health,” Sharetz said in a statement.
The FDA’s approval of a new cardiovascular disease indication could give employers and insurance companies even more reason to cover the drug, despite its high cost. At Wegovy, the list price for a package containing a month’s worth of shots is $1,349.
Health regulators can expand the use of approved medicines if new data shows that the medicines are effective in other therapeutic areas after initial approval.
Wegovy’s prescribing information includes a boxed warning regarding the risk of thyroid C-cell tumors.
The FDA said Wegovy should not be used in patients with a personal or family history of medullary thyroid cancer or a rare disease called multiple endocrine tumor syndrome type 2.
According to the FDA, Wegovy also contains warnings about pancreatic inflammation, gallbladder problems, hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy, increased heart rate, and suicidal behavior or thoughts.
Wegovy has been shown to help patients lose an average of 15 percent of their body weight after 68 weeks of treatment and was first approved by the FDA as an obesity treatment in June 2021.
Some leading U.S. obesity experts say they expect Eli Lilly’s rival weight-loss drug, Zepbound, to have similar heart benefits to Wigoby, saying the two are in the same family. This is because it belongs to the class of pharmaceutical products.
George Citroner and Reuters contributed to this report.
From the Epoch Times
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