The FDA approved once-weekly semaglutide injection for chronic weight management in adults with obesity or with overweight and at least one weight-related condition
Weekly semaglutide 2.4 mg (Wegovy, Novo Nordisk), a GLP-1 receptor agonist, is the first-approved drug for chronic weight management in adults with general obesity or overweight since 2014.
Semaglutide is indicated for chronic weight management in adults with a BMI of 27 kg/m² or greater who have at least one weight-related comorbidity, such as type 2 diabetes or hypertension, or in adults with a BMI of at least 30 kg/m².
Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program.
Safety and efficacy of semaglutide 2.4 mg was assessed in four 68-week trials. Three were randomized, double-blind, placebo-controlled trials, including 16 weeks of dose increases, and one was a double-blind, placebo-controlled, randomized withdrawal trial in which patients assigned semaglutide either continued treatment or switched to a placebo.
Semaglutide must be increased gradually over 16 to 20 weeks to 2.4 mg once weekly to reduce gastrointestinal side effects.
Semaglutide 2.4 mg should not be used in combination with other semaglutide-containing products, other GLP-1 receptor agonists or other products intended for weight loss, including prescription drugs, over-the-counter drugs and herbal products, according to the release. Semaglutide 2.4 mg has not been studied in patients with a history of pancreatitis.