‘Game-changing’ Weight Loss Drug Semaglutide Approved by FDA

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The US Food and Drug Administration approved a ‘game changing’ weight loss drug called Wegovy (semaglutide) for chronic weight management in adults with obesity or overweight.

This injection is the first drug for chronic weight management in adults with general obesity or overweight to be approved since 2014. The drug is indicated for chronic weight management in patients with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kg/m2 or greater, and is to be used in conjunction with diet and exercise.

“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said John Sharretts, MD, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in 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.”

Approximately 70% of American adults have obesity or overweight, and >67% of sub-Saharan Africans. This is a serious health issue linked to leading causes of death such as heart disease, stroke and diabetes, and also to increased risk of certain types of cancer. Losing 5% to 10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in adult patients with obesity or overweight.

Wegovy works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain regulating appetite and food intake. The medication dose must be increased gradually over 16 to 20 weeks to 2.4 mg once per week to reduce gastrointestinal side effects.

The drug’s safety and efficacy were studied in four 68-week trials. Over 2600 patients received Wegovy for up to 68 weeks in these four studies and more than 1500 patients received placebo.

The largest placebo-controlled trial enrolled diabetes free adults with an average age of 46 years, and 74% of whom were female. The average body weight was 105 kg and average BMI was 38 kg/m2. Individuals receiving Wegovy lost an average of 12.4% of their initial body weight compared to individuals who received placebo. Another trial enrolled adults with type 2 diabetes. The average age was 55 years and 51% were female, with an average body weight of 100 kg and average BMI of 36 kg/m2. In this trial, individuals receiving Wegovy lost 6.2% of their initial body weight compared to the placebo group.

“The approval of Wegovy in the US brings great promise to people with obesity. Despite the best efforts to lose weight, many people with obesity struggle to achieve and maintain weight loss due to physiological responses that favour weight regain,” said Martin Holst Lange, executive vice president, Development at Novo Nordisk. “The unprecedented weight loss for an anti-obesity medication marks a new era in the treatment of obesity, and we now look forward to making Wegovy available to people living with obesity in the US”.

Unfortunately, the drug may be out of the reach of many people in need of it, with indications being that the medication may be charged at around US$1,300 a month.

Source: Food and Drug Administration

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