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Today, the U.S. Food and Drug Administration provides Wegovy injections (weekly) for chronic weight management in obese or overweight adults with at least one weight-related condition (such as hypertension, type 2 diabetes, or obesity). Once approved 2.4 mg) is used in addition to a high cholesterol), low calorie diet and increased physical activity. This subcutaneous injection is the first drug approved for chronic weight management in general obese or overweight adults since 2014. This drug is for patients with a body mass index (BMI) of 27 kg / m2 or one or more body weight-related illnesses, or a BMI of 30 kg / m2 or greater.

“Today’s approval provides obese or overweight adults with beneficial new treatment options to incorporate into their weight management programs,” said John, Deputy Director of Diabetes, Lipid Disorders, and Obesity at the FDA Drug Evaluation Center. Dr. Sharretts said. the study. “The FDA continues to promote the development and approval of additional safe and effective treatments for obese or overweight adults.”

About 70% of American adults are obese or overweight. Obesity and overweight are serious health problems associated with major causes of death such as heart disease, stroke, and diabetes, and are associated with an increased risk of certain types of cancer. Losing 5% to 10% of body weight through diet and exercise has been shown to reduce the risk of cardiovascular disease in obese or overweight adult patients.

Wegovy works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake. To reduce gastrointestinal side effects, the dosage should be gradually increased over 16-20 weeks to 2.4 mg once a week.

Wegovy should not be used in combination with other semaglutide-containing products, other GLP-1 receptor agonists, or other weight-loss products such as prescription, over-the-counter, or herbal products. Wegovy has not been tested in patients with a history of pancreatitis.

The safety and efficacy of Wegovy was studied in four 68-week trials. Three were randomized, double-blind, placebo-controlled trials (including a 16-week dose increase) and one was a double-blind, placebo-controlled, randomized, discontinued trial in which patients receiving Wegovy were treated. Continued or switched to placebo. In these four studies, more than 2,600 patients received Wegovy for up to 68 weeks and more than 1,500 patients received placebo.

The largest placebo-controlled trial enrolled adults without diabetes. The average age at the start of the study was 46 years, with 74% of patients being female. The average weight was 231 lbs (105 kg) and the average BMI was 38 kg / m2. Individuals receiving Wegovy lost an average of 12.4% from their initial body weight compared to individuals receiving placebo. In another study, adults with type 2 diabetes were enrolled. The average age was 55, with 51% being female. The average weight was 220 pounds (100 kg) and the average BMI was 36 kg / m2. In this study, individuals receiving Wegovy lost 6.2% of their initial body weight compared to individuals receiving placebo.

The most common side effects of Wegovy are nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, dyspepsia (dyspepsia), dizziness, bloating, belching, hypoglycemia (low belching). I have (blood glucose). Type 2 diabetes, belching (accumulation of gas), gastroenteritis (intestinal infection), gastroesophageal reflux disease (a type of dyspepsia).

Wegovy’s prescribing information includes a framed warning to inform healthcare professionals and patients about the potential risk of C-cell tumors of the thyroid gland. Wegovy should not be used in patients with a personal or family history of medullary thyroid cancer or in a rare condition called multiple endocrine neoplasia syndrome type 2 (MEN 2).

Wegovy should not be used in patients with a history of severe allergic reactions to semaglutide or other ingredients of Wegovy. If a severe allergic reaction is suspected, the patient should immediately discontinue Wegovy and seek medical advice. Wegovy includes pancreatic inflammation (pancreatitis), gallbladder problems (including gallstones), hypoglycemia, acute kidney injury, diabetic retinopathy (damage to the retinopathy of the eye), increased heart rate, suicide behavior and thinking. It also contains warnings. Patients should discuss with a healthcare professional if they have symptoms of pancreatitis or gallstones. When using Wegovy with insulin or substances that cause insulin secretion, patients should consult with their healthcare provider about the possibility of reducing the dose of insulin or insulin inducers to reduce the risk of hypoglycemia. .. Health care providers need to monitor patients with renal disease, diabetic retinopathy, depression, or suicidal behavior or suicidal thoughts.

The FDA has granted Novo Nordisk approval. Semaglutide 1 mg injection (Ozempic) was first approved in 2017 for the treatment of type 2 diabetes.

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