MONDAY, June 7, 2021 (HealthDay News) — Wegovy (semaglutide) injection received the first drug approval for chronic weight management since 2014, the U.S. Food and Drug Administration announced Friday.
Wegovy 2.4 mg once weekly was approved for adults with a body mass index (BMI) of 30 kg/m2 or greater or adults with a BMI of 27 kg/m2 or greater who have at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol. The under-the-skin injection is approved as an addition to a reduced-calorie diet and increased physical activity.
The approval was based on safety and efficacy data from four trials with more than 2,600 patients who received Wegovy for up to 68 weeks. Three were randomized, double-blind, placebo-controlled trials and one was a double-blind, placebo-controlled, randomized withdrawal trial in which patients who were receiving Wegovy continued the treatment or switched to placebo. In the largest of the placebo-controlled trials, patients had an average body weight of 231 lb and an average BMI of 38 kg/m2; none had diabetes. Those who received Wegovy lost an average of 12.4 percent of their initial body weight compared with those who received placebo. In another trial of patients with type 2 diabetes, an average body weight of 220 lb, and an average BMI of 36 kg/m2, patients who received Wegovy lost 6.2 percent of their body weight compared with those who received placebo.
The most commonly reported side effects of Wegovy include nausea, diarrhea, vomiting, constipation, abdominal pain and distension, headache, fatigue, dyspepsia, dizziness, eructation, hypoglycemia in those with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease. To minimize gastrointestinal side effects, the medication dose of Wegovy must be increased gradually to 2.4 mg once a week over 16 to 20 weeks. The FDA notes that Wegovy should not be used with other products containing semaglutide, other glucagon-like peptide-1 receptor agonists, or other weight loss products.
Approval was granted to Novo Nordisk.
Copyright © 2021 HealthDay. All rights reserved.