BioCentury
ARTICLE | Company News

Arena withdrawing Belviq MAA

May 3, 2013 12:23 AM UTC

Arena Pharmaceuticals Inc. (NASDAQ:ARNA) disclosed in its 1Q13 financial results that it is withdrawing an MAA from EMA for Belviq lorcaserin to gain more feedback on the application for the obesity drug from EMA's CHMP. The MAA sought approval of the serotonin (5-HT2C) receptor agonist as an adjunct to diet and exercise for weight control in adults with a BMI of >=30 kg/m2, or adults with a BMI of >=27 kg/m2 who have associated risk factors. In March, Arena disclosed in an SEC filing that EMA's CHMP had requested the company "further justify" the overall benefit-risk balance of Belviq in light of previously identified non-clinical and clinical issues. Arena said it is "evaluating the best approach" for resubmitting the MAA (see BioCentury Extra, Jan. 22).

FDA approved Belviq last year, and the drug is now under review by the U.S. Drug Enforcement Agency for controlled substance scheduling. Arena declined to comment on a timeline. Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) has marketing rights to Belviq in North America and most of South America. ...