Novo Nordisk today announced that the Food and Drug Administration (FDA) has approved the new drug application (NDA) for Saxenda® (liraglutide [rDNA origin] injection), the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management. Saxenda® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) in the presence of at least one weight-related comorbid condition.
Saxenda® was evaluated in the SCALE™ (Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults) phase 3 clinical trial program, which included more than 5,000 study participants who have obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with comorbidities.1 Trial data showed that Saxenda®, in combination with a reduced-calorie diet and increased physical activity, resulted in significantly greater weight loss than diet and physical activity alone.1
"Many people with obesity suffer from comorbidities. Saxenda® has the potential to help some of these people achieve and maintain a clinically significant weight loss and improve certain risk factors of weight-related comorbidities," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
Currently in the United States, approximately one-third of the adult population lives with obesity,2 leaving them at risk of a myriad of conditions that can affect their overall health.3 Current guidelines recognize that a sustained weight loss of 5% to 10% provides significant health benefits for adults with obesity.4
"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," said Dr. Donna Ryan, professor and associate executive director of clinical research at the Pennington Biomedical Research Center. "The approval of Saxenda® provides us with a new therapeutic approach for helping our patients achieve and maintain a healthier body weight."
Reflecting on the approval of Saxenda® and its impact, Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition, said: "Obesity often has serious health consequences, but it has long been underdiagnosed and undertreated. We welcome new tools in the fight against obesity and anticipate that it will be a catalyst to further progress in the understanding and treatment of this complex disease."
Novo Nordisk expects to launch Saxenda® in the United States in the first half of 2015.