Weight Loss

FDA Approves New Chronic Weight Management Option

The US Food and Drug Administration (FDA) has approved wegovy (semaglutide) injection (2.4 mg once weekly) for the management of weight in adults with overweight or obesity and at least one weight-related condition. It should be used in combination with a reduced calorie diet and increased physical activity.

This is the first drug approved by the FDA for chronic weight management in this population since 2014. It is given in incrementally increased doses over the first 16 to 20 weeks of treatment to avoid gastrointestinal issues.

The safety and efficacy of this treatment option was explored in four 68-week clinical trials (3 of which were randomized, double-blind, placebo-controlled trials, and one which was a double-blind, placebo-controlled, randomized withdrawal trial) including 2600 patients given wegovy and 1500 given placebo.

In the largest trial, individuals given the drug lost an average of 12.4% of their initial body weight compared with those who were given placebo. In a trial of patients with diabetes, those given the drug lost an average of 6.2% of their initial body weight compared with placebo.

The most common side effects include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease.

—Michael Potts

Reference:

FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014. News release. US Food and Drug Administration. June 4, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014