The FDA granted approval for for the treatment of chronic weight management, combined with a 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.
In April 2020, a supplemental indication for the drug received approval from the FDA for chronic weight management in obese patients aged 12 years and older.
In March 2021, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use recommended the use of the drug for treating obesity in adolescents aged 12-17 years.
Obesity and its prevalence Obesity is a weight-related disorder that affects more than a 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 several health issues, including heart disease, type 2 diabetes and certain cancers, and results in a decreased life expectancy.
It is estimated that 80 million adults in the US suffer from obesity.
mechanism of action 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.
contains an active component called liraglutide, which is a glucagon-like peptide-1 (GLP-1) analogue. The drug reaches activated neurons in brain regions, and regulates appetite and calorie intake."
Clinical trials on The FDA's approval of 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 the drug's safety and efficacy.
Complaint
