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The Food and Drug Administration (FDA) on Friday approved a weight loss drug for overweight or obese adults, marking the first such authorization since 2014. The drug, Wegovy, is an under-the-skin injection meant to be used in addition to a reduced-calorie diet and increased physical activity.
“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” 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, said in a news release. “FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.”
The drug works by mimicking the glucagon-like peptide-1 hormone which targets areas of the brain that helps regulate appetite and food intake. The FDA warned that it should not be used in combination with other semaglutide-containing products, other GLP-1 receptor agonists, or other weight loss products including herbal products, over-the-counter drugs or prescription drugs.
The dosage is meant to be increased gradually over 16 to 20 weeks to 2.4 mg once weekly to reduce gastrointestinal side effects.
The approval comes after four 68-week successful trials which involved over 2,600 patients. The participants saw a 6.2% decrease in their initial body weight compared to an additional 1,500 patients who received a placebo.
The most common side effects reported included nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, dizziness, gas, gastroenteritis, hypoglycemia in patients with type 2 diabetes, and others.
The FDA said approximately 70% of American adults are obese, which has been linked to leading causes of deaths such as heart disease, stroke and diabetes as well as an increased risk for certain cancers. Losing 5% to 10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease among this population.
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