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.
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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.
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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.