Arena Pharmaceuticals Inc. (ARNA) and Eisai Inc. announced that the US Food and Drug Administration has notified Arena that an Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the lorcaserin New Drug Application or NDA resubmission will be held in the second quarter of 2012.
Lorcaserin is an investigational drug candidate intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition. Arena noted that it resubmitted the lorcaserin NDA in December 2011, and the FDA assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012.
Arena said that its wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States subject to FDA approval of the lorcaserin NDA.
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