The US Food and Drug Administration has approved a new drug for chronic weight control, for the first time since 2014

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Today, the US Food and Drug Administration has approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in obese or overweight adults with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high blood pressure). cholesterol), for use in addition to a reduced-calorie diet and increased physical activity. This subcutaneous injection is the first approved medication for chronic weight management in adults with general obesity or overweight since 2014. This medication is intended for chronic weight management in patients with a body mass index (BMI) of 27 kg/m2 or greater who have At least one disease associated with weight or in patients with a BMI of 30 kg/m2 or greater.

said John Sharets, MD, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity at the Center for Drug Evaluation and Research. “The Food and Drug Administration remains committed to facilitating the development and approval of additional safe and effective treatments for adults who are obese or overweight.”

Nearly 70% of American adults are obese or overweight. Obesity or being overweight is a serious health problem linked to some of the leading causes of death, including heart disease, stroke and diabetes, and is linked to an increased risk of certain types of cancer. Loss of 5% to 10% of body weight through diet and exercise was associated with a reduced risk of cardiovascular disease in overweight or obese 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. The dose of the drug should be gradually increased over 16 to 20 weeks to 2.4 mg once weekly to reduce gastrointestinal side effects.

Wegovy should not be used with other products containing semaglutide, other GLP-1 receptor agonists, or other products intended for weight loss, including prescription drugs, over-the-counter drugs, or herbal products. Wegovy has not been studied in patients with a history of pancreatitis.

The safety and efficacy of Wegovy were studied in four trials of 68 weeks duration. Three were randomized, double-blind, placebo-controlled trials (including 16 weeks of dose increase) and one was a randomized, double-blind, placebo-controlled withdrawal trial in which patients receiving Wegovy were either continuing treatment or switching to placebo. More than 2,600 patients received Wegovy for up to 68 weeks in these four studies and more than 1,500 patients received placebo.

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

The most common side effects of Wegovy include nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, indigestion (indigestion), dizziness, flatulence, belching (belching), and hypoglycemia (low sugar in the blood). blood) in patients with type 2 diabetes, flatulence (a buildup of gas), gastroenteritis (intestinal infection) and gastroesophageal reflux disease (a type of digestive disorder).

The prescribing information for Wegovy contains a boxed warning to inform healthcare professionals and patients of the potential risks 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 patients with a rare condition called multiple endocrine neoplasia type 2 (MEN 2) syndrome.

Wegovy should not be used in patients with a history of severe allergic reactions to semaglutide or any of the other ingredients of Wegovy. Patients should discontinue Wegovy immediately and seek medical help if a severe allergic reaction is suspected. Wegovy also contains warnings for pancreatitis (inflammation of the pancreas), gallbladder problems (including gallstones), low blood sugar, acute kidney injury, diabetic retinopathy (damage to the retina), increased heart rate, and suicidal behavior or thinking. Patients should discuss with their healthcare professional if they have symptoms of pancreatitis or gallstones. If Wegovy is used with insulin or a substance that causes insulin release, patients should talk to their healthcare provider about the possibility of lowering the dose of insulin or insulin stimulating medication to reduce the risk of low blood sugar. Health care providers should monitor patients for kidney disease, diabetic retinopathy, depression, or suicidal behaviors or thoughts.

The US Food and Drug Administration (FDA) has granted approval to Novo Nordisk. Semaglutide injection 1 mg (Ozempic) was first approved as a treatment for type 2 diabetes in 2017.

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The Food and Drug Administration, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary medicines, vaccines, and other biological products for human use and medical devices. The agency is also responsible for the safety and security of our nation’s food, cosmetic, and dietary supplement supplies, products that emit electronic radiation, and for regulating tobacco products.

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