The FDA has approved semaglutide (2.4 mg injection once weekly) for use in addition to a reduced calorie diet and increased physical activity for chronic weight management in adults who are obese or overweight, and have at least one concomitant weight-related conditions such as hypertension, type 2 diabetes, or high cholesterol.
Serious health issues are associated with obesity and being overweight. It is estimated that roughly 70% of Americans are either obese or overweight, and therefore, at risk for several serious diseases such as heart disease, stroke, and diabetes. Obesity is also linked to an increased risk of certain types of cancer.
“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said John Sharretts, MD, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.
Semaglutide—the first new treatment to be approved for chronic weight management since 2014—is a hormone mimic of glucagon-like peptide-1 (GLP-1), which targets the neurologic regions that regulate both appetite and food intake. It was first approved in 2017 for the treatment of type 2 diabetes.
Approval was based on four 68-week trials that included over 4,000 patients in which researchers assessed the safety and efficacy of semaglutide. In the largest of these, patients treated with semaglutide lost 6.2% of their initial body weight compared with placebo. The most common side effects of treatment included nausea, diarrhea, vomiting, constipation, and abdominal pain. Dosing must be gradually increased over 16-20 weeks to 2.4 mg weekly in order to reduce gastrointestinal side effects.
A boxed warning outlines the potential risk of thyroid C-cell tumors, and semaglutide should not, therefore, be prescribed for patients with a personal or family history of medullary thyroid cancer or in those with multiple endocrine neoplasia syndrome type 2. Full prescribing information for semaglutide will also contain warnings for inflammation of the pancreas (pancreatitis), gallbladder problems (including gallstones), low blood sugar, acute kidney injury, diabetic retinopathy (damage to the eye’s retina), increased heart rate, and suicidal behavior or thinking.
Semaglutide is manufactured by Novo Nordisk.
Liz Meszaros, Deputy Managing Editor, BreakingMED™
Cat ID: 13
Topic ID: 76,13,730,4,446,6,914,13,187,795,192,51,518,917,918,925
