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FDA approves first weight-loss drug since 2014 - Axios

The Food and Drug Administration on Friday approved Wegovy, a version of a diabetes medicine that can now be marketed and sold as a weight-loss drug in the United States.

Why it matters: The drug helped certain people lose an average of 15% of their body weight over multiple weeks when used alongside increased physical activity and a reduced calorie meal plan.

How it works: The drug, a higher-dose version of Novo Nordisk's diabetes medicine semaglutide, is meant for people who have a body mass index (BMI) of 27 kg/m2 or greater and at least one weight-related ailment or people with a BMI of 30 kg/m2 or greater.

  • Taken weekly, it works by mimicking a gut hormone that targets areas of the brain that control appetite and food intake and is intended for long-term weight management.
  • Those who took Wegovy and exercised and dieted in company-funded studies lost significantly more weight over 14 weeks than those who took a placebo while exercising and dieting.

What they're saying: “Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” John Sharretts, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said.

  • Yes, but: Dr. Archana Sadhu, head of the diabetes program at Houston Methodist Hospital, told AP that the drugs' effectiveness will largely depend on its price.
  • Novo Nordisk has not yet disclosed Wegovy’s price.

The big picture: Approximately 70% of American adults are obese or overweight, which can lead to heart disease, stroke, diabetes and an increased risk of developing certain types of cancer, according to the FDA.

  • Losing 5% body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in obese or overweight adults.
  • Wegovy is the first drug approved by the FDA for chronic weight management since 2014.

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