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The FDA to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight, the agency announced on Friday.

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

"Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight," John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity at FDA's Center for Drug Evaluation and Research, said in a statement. "This patient population has a higher risk of cardiovascular death, heart attack, and stroke."

"Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health," Sharretts added.

Underpinning the approval was the 17,600-patient SELECT trial, which included patients with overweight and obesity (with or without diabetes) as well as pre-existing cardiovascular disease.

The phase III study 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 the 3-year study, where both groups received standard-of-care medical treatment, these major adverse cardiac events occurred in 6.5% of patients on semaglutide and 8% of those on placebo.

"Semaglutide 2.4 mg is the first weight management therapy proven in a rigorous randomized trial to reduce the risk of cardiovascular events, which establishes overweight or obesity as a modifiable risk factor for cardiovascular disease," said study investigator A. Michael Lincoff, MD, of the Cleveland Clinic, when the data were presented at the American Heart Association annual meeting last year.

FDA noted that the GLP-1 receptor agonist should not be used with other agents in the class, or with other semaglutide-containing products.

Wegovy was first approved in June 2021 for chronic weight management in adults with obesity (BMI of 30 or greater) or for adults with overweight (BMI 27 or greater) with at least one weight-related condition. This indication was later expanded to include children with obesity ages 12 and up. Semaglutide is also approved for type 2 diabetes as an injectable (Ozempic) and oral drug (Rybelsus).

Consistent with the GLP-1 agonist class, common side effects with semaglutide include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with diabetes, flatulence, and gastroesophageal reflux disease.

Other warnings and precautions in the labeling include pancreatitis, gallbladder problems, hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy, increased heart rate, and suicidal behavior or thinking.

"The prescribing information for Wegovy contains 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 carcinoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2."

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