Friday, a Food and Drug Administration approved a new injectable drug to treat obesity — one shown to help people lose a significant amount of weight in clinical trials when taken on a regular basis. The drug, called Wegovy, may only signal a new era in the treatment of obesity.
Wegovy will be approved for the management of chronic weight in adults living with obesity or who are overweight with at least one health condition possibly related to their weight, such as type 2 diabetes, in conjunction with a reduced calorie diet. and physical exercise. It is taken as an injection once a week under the skin.
“Today’s approval offers adults with obesity or overweight a new beneficial treatment option to incorporate into a weight management program,” said John Sharretts, deputy director of the Division of Diabetes, Lipid Disorders and Obesity. at the FDA Center for Drug Evaluation and Research.
The active ingredient in Wegovy is semaglutide, an existing drug developed by Novo Nordisk used to manage type 2 diabetes. Semaglutide is a synthetic version of the human glucagon-like hormone peptide-1 (GLP-1), which helps regulate our sense of hunger and metabolism, among other things. In people with diabetes, the drug increases their insulin production, which then keeps their blood sugar in check. But research had also begun to show that people taking semaglutides and other GLP-1 analogs tend to lose substantial weight, which encouraged Novo Nordisk to try a higher dose (2.4 milligrams) for its treatment. obesity specifically.
The drug is the first since 2014 to be approved for obesity. But it seems to be much more effective of existing medications, almost rivaling the effectiveness seen with bariatric surgery and leading some experts to call it quits. “game changer. “In the largest 68-week trial of non-diabetic volunteers with obesity, those taking semaglutide lost, on average, 12.4% more than their initial body weight of people in placebo (both groups are have been advised on how to maintain a healthy diet and exercise) .Three other trials have shown a similar pattern of improved weight loss, as well as the sustained maintenance of that weight loss while on the drug.
Donna Ryan, an obesity researcher and professor emeritus at the Pennington Biomedical Research Center in Louisiana, told Gizmodo in an email that the results of these trials were more than enough to win her consent. “We have tons of experience on the safety side with the molecule, and the effectiveness is beyond doubt,” said Ryan, who was not affiliated with the processes used to evaluate FDA approvals. “With 42% of American adults meeting BMI criteria for obesity, we need some safe and effective tools.”
Semaglutide, like any medication, comes with side effects. Common side effects may include nausea, diarrhea, vomiting, fatigue, abdominal pain, headache, fatigue, and dyspepsia (indigestion), especially in the first few weeks of taking the drug or adjusting to a new dose. The FDA will also require a warning box indicating the potential risk of thyroid C cell tumors — a risk that has been seen in animals but not in human tests so far. People at risk for certain thyroid tumors will be warned not to take it.
Wegovy’s approval is not only important for the drug itself, but for what it could mean for the treatment of obesity going forward. There are other GLP-1 analogs being tested in clinical trials that are close to seeking approval, while research is underway to develop analogs of other intestinal hormones that also play a role in maintaining a healthy metabolism. Some initial research has already shown that it may be possible to use these drugs next to semaglutide to achieve even greater weight loss.
According to Ryan, it is likely that Wegovy will be just the first of these more recent treatments to reach the public. “The future is bright. GLP-1s are the first targets – we will then treat the other intestinal peptides and other signals from the intestinal cerebral palsy, ”he said.
While obesity has long been mistakenly seen as a matter of willpower or other personal failures, at least some obesity experts have sustinia that the effectiveness of more recent drugs like semaglutide could change people’s conceptions of obesity and allow doctors to treat it as the metabolic disorder it is.
This article has been updated to include comments from Donna Ryan.