The U.S. Food and Drug Administration (FDA) awarded Novo Nordisk an additional indication for its glucagon-like peptide-1 (GLP-1) receptor agonist, Wegovy™ (semaglutide) on March 8, 2024. It now is indicated to decrease the chance that adults who are overweight or obese and who have cardiovascular (CV) disease will have a major adverse event, such as a heart attack, stroke, or heart-related death. Obesity is defined as a body mass index (BMI) of at least 30 kg/m²; overweight as a BMI between 27 kg/m² and 30 kg/m². Administered subcutaneously (SC), Wegovy’s recommended dose is 2.4mg once per week after gradual increases once every four weeks from a starting dose of 0.25mg. When used along with a reduced caloric meal plan and increased physical activity, it has been FDA-approved since June 2021, for weight loss and management in adults who are obese or overweight and who have weight-related medical conditions. In December 2022, its use for weight management was extended to individuals as young as 12 years old whose BMIs are in the 95th percentile or higher for their peer group. Here is the updated prescribing information for Wegovy.
At a Glance
- Brand (Generic) Name: Wegovy (semaglutide)
- Manufacturer: Novo Nordisk
- Date Approved: March 8, 2024
- New Indication: to reduce the risk of major adverse CV events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults who have established CV disease and are either obese or overweight, in combination with a reduced calorie diet and increased physical activity
- Dosage Forms Available: Each package of Wegovy contains four single-dose pen devices at five different dosage levels for SC injection
- The global obesity epidemic continues to grow. The Centers for Disease Control and Prevention (CDC) estimates that 42.5% of U.S. adults age 20 years and older were obese in 2018 and 31.1% more were overweight, with no significant difference seen between genders.
- GLP-1 agonists, including Wegovy, stimulate areas of the brain that regulate appetite.
- In the SELECT clinical trial, CV-associated death was 15% lower and death due to any reason was 19% lower among patients using Wegovy than among those using a placebo.
- Wegovy contains the same active ingredient as the company’s Ozempic® SC injection, which is used weekly at a much lower dose to manage type 2 diabetes and to lessen the chance of CV events for adult patients who have both diabetes and CV disease.
- Similar to those of other GLP-1 agonists, the labeling for Wegovy contains a boxed warning about tumors of the thyroid gland (thyroid C-cell tumors) that have occurred among laboratory rodents treated with some drugs in the class during preclinical studies. Whether Wegovy causes humans to develop thyroid C-cell tumors, such as medullary thyroid carcinoma (MTC), is not yet known. Patients who have MTC, individuals with close family members who have thyroid C-cell tumors, and patients who have Multiple Endocrine Neoplasia syndrome type2 (tumors in more than one gland) are advised not to use Wegovy.