Arena Pharmaceuticals confirms FDA approval of diet drug lorcaserin

Arena Pharmaceuticals and Eisai confirmed that the FDA has approved lorcaserin 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 of 30 kg/m2 or greater, or 27 kg/m2 or greater in the presence of at least one weight related comorbid condition. The indication includes the following limitations of use: The safety and efficacy of coadministration of lorcaserin with other products intended for weight loss and the effect of lorcaserin on cardiovascular morbidity and mortality have not been established. The FDA has recommended that lorcaserin be classified by the U.S. Drug Enforcement Administration 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 lorcaserin will be available to patients and physicians in the United States. Arena will manufacture and supply the finished commercial product from its facility in Switzerland, and Eisai will market and distribute lorcaserin in the United States.