For the first time since 2014, the US Food and Drug Administration has approved a weight management pharmaceutical intended to help overweight and obese adults lose weight. Called Wegovy, the newly approved appetite suppressant is a weekly injection for overweight and obese adults who have at least one other condition related to excessive body weight, including high blood pressure, high cholesterol, or type-2 diabetes.
The approval covers a weekly 2.4mg injection of Wegovy as a chronic weight management treatment. The injection is intended to reduce one’s appetite but should be joined by exercise and dieting to create a caloric deficit. The injections are approved for obese adults or overweight adults who also have at least one condition related to their weight.
The FDA’s deputy director of the Division of Diabetes, Lipid Disorders, and Obesity John Sharretts, MD, said in a statement:
Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program. FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.
According to the FDA, this drug works by mimicking glucagon-like peptide-1 (GLP-1), a hormone that zeroes in on the brain regions behind food intake and appetite regulation. The approval was based on four 68-week trials, including randomized double-blind placebo-controlled trials.
During the trials, participants who were given the injections experienced significantly greater weight loss than those who were given the placebo. In the largest trial involving adults who didn’t have diabetes, the average weight across the participants was 231lbs. Compared to the placebo group, these participants lost an average of 12.4-percent of their starting body weight.