Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that the European Medicines Agency (EMA) has accepted the filing of a Marketing Authorization Application (MAA) for lorcaserin, an investigational drug candidate intended for weight control, 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. The acceptance of the MAA filing begins the EMA's review process.
In addition, Arena reported that the US Food and Drug Administration (FDA) has confirmed the scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the lorcaserin New Drug Application (NDA) resubmission on May 10, 2012.
"Substantial evidence shows that being overweight or obese can have dire human health consequences coupled with tremendous economic burden," said Jack Lief, Arena's President and Chief Executive Officer. "With applications under review for approval in both the United States and European Union, lorcaserin has the potential to provide a new treatment for physicians to help patients lose weight and improve their overall cardiometabolic health."
Arena's preparations for the upcoming advisory committee meeting are being led by Craig M. Audet, Arena's Vice President of Global Regulatory Affairs, Dominic P. Behan, Ph.D., Arena's Chief Scientific Officer, and William R. Shanahan, Jr., M.D., Arena's Chief Medical Officer. Following the lorcaserin NDA resubmission and MAA filing, Christen M. Anderson, M.D., Ph.D., will be retiring from Arena at the end of the month.
"We are working diligently with Eisai Inc. to prepare for the FDA advisory committee meeting in May," said Mr. Audet. "We look forward to lorcaserin's PDUFA date in June as well as reporting on developments related to the MAA throughout the year."
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