The U.S. Food and Drug Administration (FDA) has approved Wegovy (semaglutide) injection (2.4 mg once weekly) as a chronic weight management treatment in obese or overweight adults with a weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol) when used along with calorie restriction and physical activity. Wegovy, is a more potent version of Novo Nordisk's diabetes drug semaglutide.
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The under-the-skin injection is the first to be approved since 2014 for the chronic weight management of adults with general obesity or overweight. Indications for this drug are chronic weight management in patients with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kg/m2 or greater.
"Today's approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program," said John Sharretts, M.D., deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research. "FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight."
Obesity is one of the most significant health issues in the USA, resulting in several diseases, including cancers, coronary artery diseases, type 2 diabetes, strokes, as well as early mortality, and large economic costs associated with it. Studies show that reducing the body's weight by 5% to 10% can reduce the risk of cardiovascular disease in adults who are obese or overweight.
"The approval of Wegovy in the U.S. brings great promise to people with obesity. Despite the best efforts to lose weight, many people with obesity struggle to achieve and maintain weight loss due to physiological responses that favor weight regain," said Martin Holst Lange, executive vice president, Development at Novo Nordisk. “The unprecedented weight loss for an anti-obesity medication marks a new era in the treatment of obesity, and we now look forward to making Wegovy available to people living with obesity in the US”.
Wegovy targets brain areas that control appetite by mimicking a hormone called glucagon-like peptide-1 (GLP-1). A gradual increase of 2.4 mg once weekly must be made over 16 to 20 weeks to reduce gastrointestinal side effects.
"With existing drugs, you're going to get maybe 5% to 10% weight reduction, sometimes not even that," said Dr. Harold Bays, medical director of the Louisville Metabolic and Atherosclerosis Research Center. Bays, who is also the Obesity Medicine Association's chief science officer, helped run studies of Wegovy and other obesity and diabetes drugs.
Wegovy should not be combined with other products containing semaglutide, other GLP-1 receptor agonists, or other products intended to cause weight loss, including prescription medications, over-the-counter products, and herbal supplements. There have been no studies of Wegovy in patients with pancreatitis.
Four 68-week trials have been conducted to evaluate Wegovy's efficacy and safety. Wegovy was studied in three randomized, double-blind, placebo-controlled trials (including 16 weeks of dose increases). One was a double-blind, placebo-controlled, randomized withdrawal trial in which patients continued to receive the drug or switched to a placebo. More than 2,600 patients received Wegovy for up to 68 weeks in these four studies, and more than 1,500 patients received a placebo.
Participants without diabetes constituted the largest placebo-controlled trial. The average age of the patients at the start of the study was 46 years, and 74% of them were female. The average weight of the participants was 231 pounds (105 kg), and the average body mass index was 38kg/m2. Compared to individuals who received a placebo, individuals who received Wegovy lost an average of 12.4% of their initial body weight. In another trial, participants with diabetes type 2 were recruited. The average age was 55 years, and 51% of the participants were female. Those studied had an average weight of 220 pounds (100 kg) and an average body mass index of 36kg/m2. According to the results of this study, individuals who took Wegovy lost 6.2% of their starting body weight.
Among the most common side effects of Wegovy are nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, dyspepsia (indigestion), dizziness, abdominal distension, eructation (belching), hypoglycemia (low blood sugar) in patients with type 2 diabetes, flatulence (gas buildup), gastroenteritis (an intestinal infection) and gastroesophageal reflux disease (a type of digestive disorder).
Wegovy comes with a boxed warning informing healthcare professionals about the potential risk of thyroid C-cell tumors. The drug cannot be prescribed to patients with a personal or family history of medullary thyroid carcinoma, as well as patients with Multiple Endocrine Neoplasia Syndrome type 2 (MEN 2).
Patients with severe allergies to semaglutide or any other component of Wegovy should not use this medication. If a severe allergic reaction is suspected, patients should stop using Wegovy immediately and seek medical help. There are also warnings for inflammation of the pancreas (pancreatitis), gallbladder problems (including gallstones), low blood sugar, acute kidney injury, diabetic retinopathy (damage to the retina in the eye), and increased heart rate.
Any patient who experiences pancreatitis or gallstones should speak with their healthcare professional. If Wegovy is used with insulin or a substance that causes insulin secretion, patients should inform their health care provider about possibly lowering the insulin dose or the insulin-inducing drug to reduce the risk of low blood sugar. Healthcare providers should monitor patients with kidney disease, diabetic retinopathy, depression, or suicidal behaviors or thoughts.