The FDA announced Friday that it has approved semaglutide (Wegovy) to reduce the risk of cardiovascular death, heart attack, and stroke in obese or overweight adults with cardiovascular disease.

According to the FDA, semaglutide, a GLP-1 receptor agonist, should be used in conjunction with a reduced-calorie diet and increased physical activity.

“Wegovy is the first weight-loss drug approved for use in the prevention of life-threatening cardiovascular events in adults with cardiovascular disease who are obese or overweight,” said Director of Diabetes, Dyslipidemia and Obesity. says John Sharetz, MD. Researchers at the FDA’s Center for Drug Evaluation and Research said in a statement: “This patient population is at high risk for cardiovascular death, heart attack, and stroke.”

“Providing treatment options proven to reduce this cardiovascular risk is a major advance for public health,” Sharetz added.

The approval was based on the 17,600-patient SELECT study, which included overweight and obesity (with and without diabetes) and those with pre-existing cardiovascular disease. was.

A phase III trial showed that semaglutide significantly reduced the composite of cardiovascular death, heart attack, and stroke by 20% (HR 0.80, 95% CI 0.72-0.90). In a 3-year study in which both groups received standard treatment, these serious adverse cardiac events occurred in 6.5% of patients in the semaglutide group and 8% in the placebo group.

“Semaglutide 2.4 mg is the first weight management therapy proven in a rigorous randomized trial to reduce the risk of cardiovascular events, demonstrating that overweight or obesity is a modifiable risk factor for cardiovascular disease. ,” said study researcher A. Michael Linkoff, MD. The data were presented at last year’s American Heart Association Annual Meeting, held at the Cleveland Clinic.

The FDA noted that GLP-1 receptor agonists should not be used with other drugs in the same class or with other semaglutide-containing products.

Wegovy was first approved in June 2021 for chronic weight management in adults who are obese (BMI 30 or higher) or overweight (BMI 27 or higher) with at least one weight-related disease. This indication was later expanded to include obese children 12 years of age and older. Semaglutide is also approved as an injectable drug (Ozempic) and an oral drug (Rybelsus) for type 2 diabetes.

Consistent with the class of GLP-1 agonists, common side effects of semaglutide include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, dizziness, bloating, eructation, hypoglycemia in diabetics, These include bloating and gastroesophageal reflux. disease.

The label includes other warnings and precautions such as pancreatitis, gallbladder problems, hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy, increased heart rate, and suicidal behavior or thoughts.

“Wegovy’s prescribing information includes a boxed warning to inform healthcare professionals and patients about the risk of thyroid C-cell tumors,” the agency noted. “Because of this risk, 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.”