FDA approves "game-changing" new weight loss drug
The US Food and Drug Administration (FDA) has approved a new weight management drug called Wegovy (semaglutide). The drug was first approved as a type 2 diabetes treatment in 2017 and has subsequently been described as a “game-changer” for obese or overweight adults.
Semaglutide is a relatively new drug, originally developed to increase insulin secretion as a treatment for type 2 diabetics. It was approved by the FDA as a treatment for diabetes in late 2017.
The drug works by mimicking the actions of a naturally-occurring hormone called GLP-1. As well as influencing blood sugar levels, GLP-1 has been found to play a role in suppressing appetite. The hormone is produced by intestinal cells helping tell the brain when we have eaten enough food.
Several large recently completed Phase 3 trials testing the drug as a weight-loss treatment saw average reductions of 15.3 kg (33.7 lb) after 68 weeks. This made the drug more effective than any other currently available weight-loss medication.
The dose of semaglutide used in Wegovy is around double what is used to treat type 2 diabetes. The drug is administered via a once-weekly sub-cutaneous injection and the FDA notes the treatment is approved for, “chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol).”
It is important to note the trials testing semaglutide for weight loss included significant behavioral changes in their protocols. Alongside the weekly injection all subjects were directed to follow a calorie-controlled diet and engage in at least 150 minutes of physical activity each week.
“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” says John Sharretts, from the FDA’s Center for Drug Evaluation and Research. “FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.”
Novo Nordisk, the pharmaceutical company behind Wegovy, is yet to reveal the market price of the drug but it has been predicted to cost over US$1,000 per month. The current monthly cost of semaglutide for type 2 diabetes is over $850.