The FDA has approved liraglutide injection (Saxenda, Novo Nordisk) as an adjunct to diet and exercise for chronic weight management, according to a press release from the manufacturer.
The once-daily glucagon-like peptide-1 (GLP-1) receptor agonist is indicated for use in adults with obesity, defined as a BMI of 30 or greater, or those who are overweight, defined as a BMI of 27 or greater, with at least one-related comorbidity, such as diabetes.
The FDA’s decision to approve Saxenda follows a 14-1 vote in favor of approval of the drug for chronic weight management from the agency’s Endocrinologic and Metabolic Drugs Advisory Committee on Sept. 12, 2014.
The agency based its approval on results from the Satiety and Clinical Adiposity–Liraglutide Evidence in Non-diabetic and Diabetic Adults (SCALE) phase 3 clinical trial program. More than 5,000 obese and overweight participants were included in the study.
Data showed that those taking liraglutide in combination with a reduced-calorie diet and increased exercise, experienced greater weight loss vs. diet and exercise alone, according to the release.
“Obesity has many root causes and there is a clear need for additional treatment options to help health care professionals better address our patients’ individual conditions and goals for weight management,” Donna Ryan, MD, professor and associate executive director of clinical research at the Pennington Biomedical Research Center, said in the release.
“The approval of Saxenda provides us with a new therapeutic approach for helping our patients achieve and maintain a healthier body weight.”
Liraglutide 1.2 mg and 1.8 mg were approved under the brand name Victoza for treatment of type 2 diabetes in 2010. Saxenda, however, is not indicated for treatment of type 2 diabetes. Further, it should not be used in combination with any other GLP-1 receptor agonist or insulin.