Arena Pharma (ARNA) Confirms FDA Panel Voted Benefits of Lorcaserin Outweigh Risks
Tweet Send to a Friend
Up)
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today that the US FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, that the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals. Lorcaserin is an investigational drug candidate intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI greater than or equal to 30) or patients who are overweight (BMI greater than or equal to 27) and have at least one weight-related co-morbid condition.
"The advisory committee's positive vote supports our belief in lorcaserin as a potential new treatment option for the medical management of overweight and obesity," said Jack Lief, Arena's President and Chief Executive Officer. "We will continue to 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 Prescription Drug User Fee Act (PDUFA) date for the lorcaserin New Drug Application (NDA) resubmission is June 27, 2012, which is the target date for the agency to complete its review.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
"The advisory committee's positive vote supports our belief in lorcaserin as a potential new treatment option for the medical management of overweight and obesity," said Jack Lief, Arena's President and Chief Executive Officer. "We will continue to 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 Prescription Drug User Fee Act (PDUFA) date for the lorcaserin New Drug Application (NDA) resubmission is June 27, 2012, which is the target date for the agency to complete its review.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
You May Also Be Interested In
- Alnylam (ALNY) Updates on Preclinical Data for RNAi Program Targeting ALAS-1
- Novo Nordisk (NVO) Reports Positive Results from Paradigm 2
- U.S. SEC Appoints Lona Nallengara as Chief of Staff; Keith Higgins as Corp. Finance Director
Create E-mail Alert Related Categories
Corporate News, FDA
Login with Facebook
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
