US FDA approves obesity drug Wegovy: Safety, efficacy and side effects
According to the US Food and Drug Administration (FDA), the safety and efficacy of Wegovy, a higher-dose version of Novo Nordisk’s diabetes drug semaglutide, were studied in four 68-week trials.
The US Food and Drug Administration (FDA) on Friday approved a new version of popular diabetes medicine to be sold as a weight-loss drug in the United States. In addition to a reduced-calorie diet and increased physical activity, the doctors will now be ableto prescribe injectable drug Wegovy, a higher-dose version of Novo Nordisk's diabetes drug semaglutide, for chronic weight management.
Wegovy is the first approved drug for chronic weight management in adults with general obesity or overweight since 2014. The drug is indicated for chronic weight management in adults with obesity or overweight with at least one weight-related condition like high blood pressure, type 2 diabetes, or high cholesterol.
Wegovy's safety and efficacy
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According to the FDA, the safety and efficacy of Wegovy were studied in four 68-week trials, in which more than 4,100 patients participated. Over 2,600 patients received Wegovy for up to 68 weeks and more than 1,500 patients received placebo during these four trials.
In a trial that enrolled adults without diabetes, the average body weight of participants was 105 kg and 74 per cent were female. Those who received this under-the-skin injection lost an average of 12.4 per cent of their initial body weight compared to those who received placebo.
In another trial that enrolled adults with type 2 diabetes, the average body weight was 100 kg and 51% of the patients were female. Individuals who received Wegovy under this trial lost 6.2 per cent of their initial body weight compared to those who received placebo.
Side effects of Wegovy
The US FDA said that that the most common side effect of Wegovy includes nausea, diarrhoea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, dizziness, abdominal distension, eructation, low blood sugar in patients with type 2 diabetes, gastroenteritis and gastroesophageal reflux disease (a type of digestive disorder).
Warnings about Wegovy use
Wegovy contains a boxed warning, informing healthcare professionals and patients about the potential risk of thyroid C-cell tumours. It also contains warnings for inflammation of the pancreas, gallbladder problems, low blood sugar, acute kidney injury, damage to the eye's retina, increased heart rate and suicidal behaviour or thinking. FDA has warned against its use in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2.
"Having obesity or overweight is a serious health issue associated with some leading causes of death, including heart disease, stroke and diabetes, and is linked to an increased risk of certain types of cancer," the FDA said in a statement, adding that losing 5-10 per cent of body weight has been associated with a reduced risk of cardiovascular disease.
