Arena Pharmaceuticals submits lorcaserin NDA to the FDA

Dec 22 2009

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss. The submission is based on an extensive data package from lorcaserin's clinical development program that includes 18 clinical trials totaling 8,576 patients.

William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer, stated, "Physicians need new, better-tolerated approaches to improve the treatment of patients who are obese or significantly overweight. Based on the robust data package we submitted to the FDA, lorcaserin has the potential to meet this need, offering patients the opportunity to achieve sustainable weight loss in a well-tolerated manner and improve their cardiometabolic health and quality of life."

The pivotal Phase 3 clinical trial program, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), evaluated nearly 7,200 patients treated for up to two years and showed that lorcaserin consistently produced significant weight loss with excellent safety and tolerability.

"Today's NDA submission is an important milestone towards realizing lorcaserin's significant commercial potential, and we are excited by the possibility of bringing lorcaserin to patients who need help in managing their weight," said Jack Lief, Arena's President and Chief Executive Officer. "Physician feedback suggests that, if approved, lorcaserin's combination of efficacy, safety and tolerability will position the drug candidate as first-line therapy for weight management."