FDA Approves Drug to Treat Obese and Overweight Adults
- Thu, 7/19/12 - 2:36pm
- 0 Comments
On June 27, 2012, the FDA approved Belviq (lorcaserin hydrochloride) 10-mg tablets for chronic weight management in obese adults (body mass index [BMI], >30 kg/m2), and in overweight adults (BMI, >27 kg/m2) who also have at least one weight-related condition, such as hypertension, type 2 diabetes, or high cholesterol levels. According to a recently published study in JAMA, nearly 70% of adults over the age of 60 years are overweight or obese. “The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition,” said Janet Woodcock, MD, director, FDA Center for Drug Evaluation and Research, in a press statement.
Belviq works by activating serotonin 2C receptor (5-HT2CR) in the brain, which may help persons taking the drug to eat less and feel full after eating smaller amounts of food. The safety and efficacy of the drug were demonstrated in three randomized, placebo-controlled trials that included approximately 8000 obese and overweight people, with and without type 2 diabetes, who were treated for 52 to 104 weeks. When combined with a reduced calorie diet and exercise, treatment with Belviq for up to 1 year was associated with an average weight loss of between 3% and 3.7%.
Nearly 47% of nondiabetic patients taking Belviq lost at least 5% of their body weight, compared with 23% of patients treated with placebo. In those with type 2 diabetes, approximately 38% of patients taking Belviq lost at least 5% of their body weight, compared with 16% of patients treated with placebo. Treatment with Belviq in the diabetic arm was also associated with favorable changes in glycemic control. Belviq is the first FDA-approved prescription weight-loss drug in more than a decade. Full prescribing information is accessible at http://bit.ly/Belviq_PI.