Wegovy Approved for Chronic Weight Management

Wegovy Approved for Chronic Weight Management

June 4, 2021 – The U.S. FDA has approved WegovyTM (semaglutide), manufactured by Novo Nordisk, as an adjunct to diet and exercise for chronic weight management in adults who have an initial body mass index (BMI) of at least 27kg/m 2 and at least one weight-related comorbidity.

BMI is used as one method to screen weight categories, with the categories defined as underweight, healthy weight, overweight, and obese. For adults, a BMI of 25kg/m 2 -29.9kg/m 2 is considered overweight, while a BMI of 30kg/m 2 or more is considered obese. Obesity is associated with an increased risk of many chronic health conditions, including high blood pressure, high cholesterol, type 2 diabetes, heart disease, arthritis, sleep apnea, pain, depression, and certain cancers.

In clinical trials, individuals taking Wegovy who were diagnosed with obesity experienced an average weight loss of 17-18% sustained over 68 weeks. The drug helps reduce feelings of hunger and increase feelings of being full, thereby helping to reduce calorie intake. Recommended dosing is 2.4mg taken once a week as a subcutaneous (SC) injection. The medication can be self-administered or administered by a caretaker after receiving instruction on proper technique from a healthcare provider.

Semaglutide, the active pharmaceutical ingredient of Wegovy, has been FDA approved since 2017 under the brand name Ozempic® as a 0.5mg or 1mg SC injection to treat type 2 diabetes. In 2019, the FDA approved an oral formulation, sold under the brand name Rybelsus®, to treat type 2 diabetes. Ozempic gained a second indication in 2020 to reduce the risk of major adverse cardiovascular events in adults who have type 2 diabetes and established cardiovascular disease.

Novo Nordisk manufactures and distributes both Ozempic and Rybelsus. The company has launched Wegovy at a wholesale acquisition cost (WAC) of $1,349.02 per 28 days.