Arena Pharmaceuticals, Inc. And Eisai Announce FDA Approval Of BELVIQ for Chronic Weight Management In Adults who are Overweight With Comorbidity Or Obese

Arena Pharmaceuticals, Inc. and Eisai Inc. announced that the U.S. Food and Drug Administration (FDA) has approved BELVIQ (pronounced BEL-VEEK) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes). The indication includes the following limitations of use: The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss and the effect of BELVIQ on cardiovascular morbidity and mortality have not been established. Three double-blind, randomized, placebo-controlled trials demonstrated that BELVIQ along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after one year and managing the weight loss for up to two years. The FDA has recommended that BELVIQ be classified by the U.S. Drug Enforcement Administration (DEA) as a scheduled drug. The DEA will review the FDA's recommendation and determine the final scheduling designation. Once the DEA has provided the final scheduling designation, Eisai will announce when BELVIQ will be available to patients and physicians in the United States.