Arena Pharmaceuticals Submits New Drug Application to FDA for Lorcaserin forWeight Management
Tue, 12/22/2009 - 3:37am
Arena Pharmaceuticals,Inc. has submitted a New DrugApplication (NDA) to the FDA for lorcaserin,Arena's internally discovered and developed drug candidate for weightmanagement, including weight loss and maintenance of weight loss. Thesubmission is based on an extensive data package from lorcaserin's clinicaldevelopment program that includes 18 clinical trials totaling 8,576 patients.William R. Shanahan, M.D., Arena's Vice President and Chief MedicalOfficer, stated, "Physicians need new, better-tolerated approaches to improvethe treatment of patients who are obese or significantly overweight. Based onthe robust data package we submitted to the FDA, lorcaserin has the potentialto meet this need, offering patients the opportunity to achieve sustainableweight loss in a well-tolerated manner and improve their cardiometabolichealth and quality of life." The pivotal Phase 3 clinical trial program, BLOOM (Behavioral modificationand Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioralmodification and LOrcaserin Second Study for Obesity Management), evaluatednearly 7,200 patients treated for up to two years and showed that lorcaserinconsistently produced significant weight loss with excellent safety andtolerability. "Today's NDA submission is an important milestone towards realizinglorcaserin's significant commercial potential, and we are excited by thepossibility of bringing lorcaserin to patients who need help in managing theirweight," said Jack Lief, Arena's President and Chief Executive Officer."Physician feedback suggests that, if approved, lorcaserin's combination ofefficacy, safety and tolerability will position the drug candidate asfirst-line therapy for weight management." Phase 3 Program Overview BLOOM and BLOSSOM comprise the pivotal Phase 3 program and are the basisof the lorcaserin NDA submission. These double-blind, randomized,placebo-controlled trials evaluated 10 mg of lorcaserin dosed once or twicedaily versus placebo for up to two years in obese patients, Body Mass Index(BMI) 30 to 45, with or without co-morbid conditions and overweight patients,BMI 27 to 29.9, with at least one co-morbid condition. Positive results fromthe pivotal program were presented at the 69th Scientific Sessions of theAmerican Diabetes Association and the 27th Annual Scientific Meeting of TheObesity Society. In addition to the pivotal program, Arena is evaluating lorcaserin inobese and overweight patients with type 2 diabetes in its BLOOM-DM (Behavioralmodification and Lorcaserin for Overweight and Obesity Management in DiabetesMellitus) trial. BLOOM-DM is planned as a supplement to the NDA.