The U.S. Food and Drug Administration (FDA) has granted approval to Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight, who have at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol). This approval marks the first for chronic weight management in adults with general obesity or overweight since 2014. Wegovy is indicated for use in addition to a reduced-calorie diet and increased physical activity.
Approximately 70% of American adults are affected by obesity or overweight, conditions associated with serious health risks such as heart disease, stroke, diabetes, and certain types of cancer. Losing 5% to 10% of body weight through diet and exercise has been linked to a reduced risk of cardiovascular disease in adults with obesity or overweight.
Wegovy works by mimicking a hormone called glucagon-like peptide-1 (GLP-1), which targets areas of the brain regulating appetite and food intake. The medication is administered via an under-the-skin injection and requires a gradual dosage increase over 16 to 20 weeks to 2.4 mg once weekly to minimize gastrointestinal side effects.
The safety and efficacy of Wegovy were demonstrated in four 68-week trials, including randomized, double-blind, placebo-controlled trials and a withdrawal trial. In these trials, individuals receiving Wegovy experienced significant weight loss compared to those receiving a placebo.
Common side effects of Wegovy include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, belching, hypoglycemia in patients with type 2 diabetes, gas buildup, gastroenteritis, and gastroesophageal reflux disease.
The prescribing information for Wegovy includes a boxed warning about the potential risk of thyroid C-cell tumors. It is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in those with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Patients with a history of severe allergic reactions to semaglutide or any components of Wegovy should not use the medication. The drug also carries warnings for inflammation of the pancreas, gallbladder problems (including gallstones), low blood sugar, acute kidney injury, diabetic retinopathy, increased heart rate, and suicidal behavior or thinking.
Novo Nordisk, the pharmaceutical company, is the sole entity with FDA-approved products containing semaglutide. Wegovy is an addition to their portfolio, which includes Semaglutide 1 mg injection (Ozempic), initially approved for treating type 2 diabetes in 2017.
Related Information
NIH Statistics on Overweight and Obesity
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Credited Source: FDA
