FDA Accepts Resubmission Of Arena Pharmaceuticals And Eisai Inc's Lorcaserin New Drug Application

Arena Pharmaceuticals and Eisai Inc. announced that the US Food and Drug Administration (FDA) has accepted for filing and review Arena's resubmission of the New Drug Application (NDA) for lorcaserin. The FDA considers the resubmission a complete, class 2 response, and assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition. Arena submitted the original NDA for lorcaserin in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. Arena submitted a response to the lorcaserin CRL in December 2011.