Drug (Brand / Generic)
Saxenda / liraglutide
Saxenda (liraglutide (rDNA origin)) is a newly approved injection for the treatment of obesity and chronic weight management. It was discovered and developed by Novo Nordisk.
Novo Nordisk received favourable votes of 14-1 for the approval of Saxenda for weight management from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) panel of US Food and Drug Administration (FDA) in September 2014.
The FDA granted approval for Saxenda for the treatment of chronic weight management, along with reduced-calorie diet and physical activity in December 2014.
The drug is designed for adults with obesity (body mass index (BMI) >30) or overweight (BMI >27) and also affected with one obesity-related condition such as type 2 diabetes, cardiovascular disease, hypertension or high cholesterol.
Marketing authorisation application (MAA) for Saxenda is currently under review by the European Medicines Agency (EMA).
Obesity is a weight-related disorder that affects more than one-third of adults in the US. The condition can be measured using BMI, the measurement of body fat based on the person’s height and weight.
Obesity can lead to complications including heart diseases, type 2 diabetes and certain cancers and results in decreased life expectancy.
It is estimated that 80 million adults in the US suffer from obesity.
Saxenda contains an active component called liraglutide, which is a glucagon-like peptide-1 (GLP-1) analogue. The drug, which can be administered intravenously, reaches activated neurons in brain regions and regulates the appetite and calorie intake.
Contrave is an anti-obesity drug which reduces appetite or inhibits fat absorption.
FDA approval for Saxenda was based on results from three Phase III clinical trials known as SCALE (Satiety and Clinical Adiposity−Liraglutide Evidence in Nondiabetic and Diabetic people) studies, which were conducted for 56 weeks to evaluate safety and efficacy of the drug.
The three Phase III SCALE clinical trials enrolled more than 5,000 participants who were obese or overweight and with or without other weight-related conditions.
The first Phase III clinical trial was a randomised, double-blind, placebo-controlled study. It enrolled 3,731 patients with obesity. The second Phase III study enrolled 635 patients with type 2 diabetes and with either overweight or obesity, while the third Phase III study enrolled 422 patients with obesity.
Patients were administered with Saxenda 3mg daily dose or a placebo for 56 weeks and were given counselling about lifestyle changes they need to adopt related to a low-calorie diet and regular physical exercise.
Primary efficacy parameters of the first and second Phase III clinical studies included mean per cent change in body weight and the percentages of patients achieving greater than or equal to 5% and 10% weight loss from baseline to week 56.
The primary efficacy parameters of the third Phase III study included percentage change in body weight from randomisation, the percentage of patients not gaining more than 0.5% body weight from randomisation and the percentage of patients achieving greater than or equal to 5% weight loss from randomisation to week 56.
The study results demonstrated that patients treated with Saxenda experienced a statistically significant reduction in weight, compared with a placebo after 56 weeks. Patients treated with Saxenda achieved 5% and 10% weight loss, compared to a placebo.
The most serious side effects reported during the trials in patients treated with Saxenda included pancreatitis, gallbladder disease, renal impairment and suicidal thoughts.
Novo Nordisk plans to introduce Saxenda in the US market in the first half of 2015. Another medication available in the market for the same indication is Contrave, which was developed by Orexigen Therapeutics and Takeda Pharmaceutical.
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