Wegovy — an under-the-skin injection that showed promise in weight-loss clinical trials — is the first drug approved for chronic weight management since 2014.
This product packaging promotional photo shows the newly FDA-approved injectable medication Wegovy. is now fully approved for certain obese or overweight Americans. of pharmaceutical giant Novo Nordisk's Wegovy injection for adults who either have obesity or are overweight and have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
Wegovy is the first drug approved for chronic weight management since 2014, according to the agency. The FDA is not calling Wegovy a "weight-loss shot" but rather "a beneficial new treatment option" for Americans to "incorporate into a weight management program," according to the FDA's Dr. John Sharrett.
"FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight," Sharrett said., the FDA said. Patients start with a lower dose and then gradually — over about four to five months — increase the weekly dosage to 2.4 milligrams. This is done to reduce gastrointestinal side effects, the FDA said.
Wegovy is actually just a higher dosage of the same active ingredient — semaglutide — used in Ozempic, which is an injection treatment for type 2 diabetes approved in 2017. The full Wegovy dose is 2.4 milligrams of semaglutide whereas the typical Ozempic dose is 1 milligram of semaglutide."One key misunderstanding is that [obesity] is a disease of willpower, when in fact there is underlying biology that prevents people from losing weight and keeping it off,".
Wegovy works by mimicking a gut hormone that targets parts of your brain that regulate appetite and food intake, according to the FDA. This naturally occurring hormone is called glucagon-like peptide-1, or GLP-1, and it helps people feel full when they eat, according to researchers.The drug was studied in four trials each lasting 68 weeks. In these studies, more than 2,600 patients received Wegovy for up to 68 weeks and more than 1,500 patients received a placebo.
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