Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin

Arena Pharmaceuticals, Inc.ARNA -2.56% and Eisai Inc. announced today that the US Food and Drug Administration (FDA) has notified Arena that an Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the lorcaserin New Drug Application (NDA) resubmission will be held in the second quarter of 2012. Confirmation and details of the meeting will be published in the Federal Register.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 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.

No comments:

Post a Comment

Superhit News

News Archive