Complaint
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, according to an agency press release.
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
Semaglutide 1 mg injection (Ozempic) was first approved as a treatment for type 2 diabetes in 2017.
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
