Arena, Eisai provide update on lorcaserin NDA

Sep 17 2010

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced today that the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 9 to 5 that the available data do not adequately demonstrate that the potential benefits of lorcaserin outweigh the potential risks, when used long-term in a population of overweight and obese individuals to allow marketing approval. Lorcaserin, which Arena discovered and has developed, 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.

"We believe that lorcaserin has a positive benefit-risk profile and represents a potential advance in the treatment of obesity," said Jack Lief, Arena's President and Chief Executive Officer. "We will work with the FDA as the agency completes its review of the lorcaserin new drug application."  

Although advisory committees provide recommendations to the FDA, the agency makes the final decisions. The FDA has assigned a PDUFA date, the target date for the agency to complete its review of the lorcaserin New Drug Application (NDA), of October 22, 2010.

SOURCE Arena Pharmaceuticals, Inc.