Featured Article Main Category: Obesity / Weight Loss / Fitness Also Included In: Regulatory Affairs / Drug Approvals Article Date: 28 Jun 2012 - 3:00 PDT
Current ratings for: Weight Loss Pill Belviq Gets FDA Approval
Belviq (lorcaserin hydrochloride), made by the Swiss pharma company Arena, is the first prescription diet drug to receive US federal approval in over a decade. It works by activating the serotonin 2C receptor in the brain, an effect that may help the patient feel full after eating smaller amounts of food and thereby eat less.
Dr Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, told the press:
"Obesity threatens the overall well being of patients and is a major public health concern."
FDA says the drug is approved for use in adults who are obese, or adults who are overweight and have at least one weight-related condition, such as type 2 diabetes, high blood pressure, or high cholesterol.
"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 Woodcock.
The agency defines obesity as having a BMI of 30 or over, and overweight as having a BMI under this but no less than 27. BMI stands for Body Mass Index, and equals weight in kilos divided by the square of height in metres.
BMI is used by health authorities and policymakers as a measure of body fat. According to the US Centers for Disease Control and Prevention (CDC), more than one in three of adult Americans is obese.
The approved label for Belviq recommends that patients stop using it if they fail to lose 5% of their body weight after 12 weeks of treatment, as "these patients are unlikely to achieve clinically meaningful weight loss with continued treatment," says the FDA in their announcement.
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Weight Loss Pill Belviq Gets FDA Approval
