Arena Pharmaceuticals and Eisai : FDA Accepts Resubmission of Lorcaserin New Drug Application

Jan. 10, 2012 - Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) 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.

About Lorcaserin

Lorcaserin is an investigational new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain... Arena Pharmaceuticals' Press Release - [PDF] Eisai's Press Release -