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Obesity Drug Saxenda (Liraglutide) Launched in U.S.
Saxenda (liraglutide 3 mg, Novo Nordisk), the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for weight management in the U.S. –– is now available for clinical use in this country. The drug is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (body mass index [BMI] greater than or equal to 30 kg/m2) or who are overweight (BMI greater than or equal to 27 kg/m2) in the presence of at least one weight-related comorbid condition.
Liraglutide was evaluated in the phase III SCALE (Satiety and Clinical Adiposity: Liraglutide Evidence in Nondiabetic and Diabetic People) clinical trial program, which involved more than 5,000 study participants who had obesity or who were overweight, with weight-related comorbidities. The trial data showed that liraglutide, in combination with a reduced-calorie diet and increased physical activity, resulted in greater weight loss compared with a reduced-calorie diet and physical activity alone.
Recognized as a disease by the American Medical Association and other medical societies, obesity has grown in prevalence in the U.S. and around the world. Affecting approximately 35% of the U.S. adult population in 2011–2012, obesity is associated with serious comorbidities, including type-2 diabetes, heart disease, and certain types of cancer.
Liraglutide is a once-daily GLP-1 analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake. Like human GLP-1, liraglutide regulates the appetite and lowers body weight through decreased food intake. As with other GLP-1 receptor agonists, liraglutide stimulates insulin secretion and reduces glucagon secretion in a glucose-dependent manner. These effects can lead to a reduction of blood glucose.
The labeling for Saxenda includes a boxed warning regarding the risk for thyroid C-cell tumors. The most common adverse events related to treatment include nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase.
Sources: Novo Nordisk; April 22, 2015; and Saxenda Prescribing Information; January 2015.