Arena Pharmaceuticals, Inc. 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 totalling 8,576 patients.
William R. Shanahan, 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 programme, 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."
BLOOM and BLOSSOM comprise the pivotal phase 3 programme and are the basis of the lorcaserin NDA submission. These double-blind, randomized, placebo-controlled trials evaluated 10 mg of lorcaserin dosed once or twice daily 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 from the pivotal program were presented at the 69th Scientific Sessions of the American Diabetes Association and the 27th Annual Scientific Meeting of The Obesity Society.
In addition to the pivotal programme, Arena is evaluating lorcaserin in obese and overweight patients with type 2 diabetes in its BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial. BLOOM-DM is planned as a supplement to the NDA.
Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.