Washington, D.C. -- The U.S. Food and Drug Administration recently approved a new drug that can help adults manage obesity. It's the first drug targeted towards wieght management since 2014.
Wegovy (semaglutide) is given via injections once weekly for chronic weight management in adults with obesity or overweight with at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The drug is meant to be used in addition to a reduced-calorie diet and increased physical activity.
Wegovy contains the same active ingredient as Ozempic, a lower-dose type 2 diabetes treatment approved by the FDA in 2017.
The under-the-skin injection is the first approved drug for chronic weight management in adults with general obesity since 2014. The drug is intended for patients with a body mass index of 27 kg/m2 or higher with at least one weight-related ailment or in patients with a BMI of 30 kg/m2 or greater.
The drug's approval "offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said John Sharretts, M.D., deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.”
According to the FDA, approximately 70% of American adults are obese or overweight, which is linked to heart disease, stroke, diabetes, and increased risks of certain types of cancer. Losing five to ten percent of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in obese or overweight adult patients.
Wegovy works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake. The medication dose must be increased gradually over 16 to 20 weeks. The gradual increase is to reduce gastrointestinal side effects.
Wegovy should not be used in combination with other semaglutide-containing products, other GLP-1 receptor agonists or other products intended for weight loss such as prescription drugs, over-the-counter drugs, or herbal products. The drug has not been studied in patients with a history of pancreatitis at this time.
The most common side effects during testing were nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, dyspepsia (indigestion), dizziness, abdominal distension, eructation (belching), hypoglycemia (low blood sugar) in patients with type 2 diabetes, flatulence (gas buildup), gastroenteritis (an intestinal infection) and gastroesophageal reflux disease (a type of digestive disorder).