The US Food and Drug Administration (FDA) has approved the use of a new drug treatment for chronic weight management, the first the agency has approved since 2014. The drug, Wegovy, is based on the molecule semaglutide which was recently shown to have a significant impact in helping weight loss.
The drug has been approved as a 2.4-milligram, once-weekly injection for adults who are obese or overweight and dealing with a weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” Dr John Sharretts, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a statement. “FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.”
An international study on the weight-loss property of this drug was published back in February. Semaglutide is approved widely at lower dosages as a treatment for type 2 diabetes as the molecule mimics the action of a naturally occurring hormone that is released by our bodies after a meal and makes us feel full.
Losing between 5 and 10 percent of body weight through diet and exercise is associated with reduced risks of cardiovascular disease in adults who are overweight or obese. This is what has been seen in the vast majority of the 1,961 people in one of the four clinical trials for this drug.
In the earlier study, 86.4 percent of participants had shed at least 5 percent of their body weight. Half of them shed 15 percent of their body weight, and just over one-third shed 20 percent of their body weight, making the drug a potentially exciting new tool in weight management. Such weight loss has previously only been possible through surgery. People in the trial also received dietary advice and counseling on ways to increase their physical activity.
The FDA advice is to slowly get to the 2.4-milligram dosage over the course of several months to mitigate the possible and temporary side effects that include vomiting and diarrhea.
While the drug has potential, many experts stress that it is not a magic bullet, and whether weight loss can be maintained is the next concern. The trial did not look at weight trends once the volunteers stopped taking the drug. Long-term management is key for people to stay healthy and reduce the risks of diseases linked to obesity.
"While drug like this may prove useful in the short term for obtaining rapid weight loss in severe obesity, they are not a magic bullet for preventing or treating less severe degrees of obesity and public health measures that encourage behavioural changes such as regular physical activity and moderating dietary energy intake are still needed," Professor Tom Sanders, Professor Emeritus of Nutrition and Dietetics at King’s College London, commented. "It is rather like the situation we are in with the [COVID] vaccine, we still need to stick with public health measures and not become overdependent on medicines.”