Wegovy FDA Approval History
Last updated by Judith Stewart, BPharm on March 8, 2024.
FDA Approved: Yes (First approved June 4, 2021)
Brand name: Wegovy
Generic name: semaglutide
Dosage form: Injection
Company: Novo Nordisk
Treatment for: Weight Loss (Obesity/Overweight), Cardiovascular Risk Reduction
Wegovy (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist used for weight management and cardiovascular risk reduction in people with obesity or overweight.
- Wegovy is indicated in combination with a reduced calorie diet and increased physical activity:
- to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.
- to reduce excess body weight and maintain weight reduction long term in:- adults and pediatric patients aged 12 years and older with obesity
- adults with overweight in the presence of at least one weight-related comorbid condition.
- Limitations of Use: Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.
- Wegovy works by decreasing caloric intake by activating GLP-1 receptors, which are present in several areas of the brain involved in appetite regulation.
- Wegovy is administered by subcutaneous injection once weekly, with or without meals.
- The Wegovy product label carries a boxed warning for an increased risk of thyroid C-cell tumors.
- Warnings and precautions include acute pancreatitis, acute gallbladder disease, hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy complications in patients with type 2 diabetes, increased heart rate, and suicidal behavior and ideation.
- Common adverse reactions in adults or pediatric patients aged 12 years and older include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.
Development timeline for Wegovy
Further information
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