The US Food and Drug Administration (FDA) has granted a seal of approval to Wegovy (semaglutide), Novo Nordisk’s injectable treatment (2.4 mg once a week) intended for chronic weight management in adults with obesity or that are overweight, with at least one weight-related condition (i.e. high blood pressure, type 2 diabetes or high cholesterol.
The treatment, recommended in conjunction with the adoption of a reduced-calorie diet and increased physical activity, is indicated for 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.
“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said John Sharretts, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research (CDER). “FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.”
According to the FDA, about 70% of adults in the US have obesity or are overweight, conditions associated with several potentially fatal conditions (such as heart disease, stroke, and diabetes), and linked to increased risk of certain cancers. Losing 5% to 10% of body weight has been associated with a reduced risk of cardiovascular disease in obese or overweight adults.
“Despite the best efforts to lose weight, many people with obesity struggle to achieve and maintain weight loss due to physiological responses that favor weight regain,” said Martin Holst Lange, executive vice president of 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.”
Wegovy reportedly works by mimicking a hormone called glucagon-like peptide-1 (GLP-1); the hormone targets areas of the brain that regulate appetite and food intake. The dose must be increased gradually over 16 to 20 weeks to 2.4 mg once a week in order to reduce potential gastrointestinal side effects.
Wegovy was evaluated in four 68-week trials. Three were randomized, double-blind, placebo-controlled trials (including 16 weeks of dose increases) and one was a double-blind, placebo-controlled, randomized withdrawal trial in which patients receiving Wegovy either continued with the treatment or switched to a placebo; patients across the trials reportedly lost slightly more than 12.4% of their body weight, while patients not diagnosed with type 2 diabetes lost up to 18% on average.
The drug is expected to launch in the US later this month. FDA first approved semaglutide in 1-mg injections as a treatment for Type 2 diabetes in 2017, under the brand name Ozempic.