BelviqTreatment for Obesity
Update: Belviq (lorcaserin) Now FDA Approved - June 27, 2012
Arena Pharmaceuticals Submits New Drug Application to FDA for Lorcaserin for Weight Management
SAN DIEGO, Dec 22, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- 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."
Phase 3 Program Overview
BLOOM and BLOSSOM comprise the pivotal Phase 3 program 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 program, 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.
About Arena Pharmaceuticals
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. Arena has submitted a New Drug Application to the FDA for its most advanced drug candidate, lorcaserin for weight management.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the development, advancement, therapeutic indication and use, tolerability, safety, selectivity, efficacy and regulatory approval of lorcaserin; the importance of Arena's NDA submission for lorcaserin; lorcaserin's commercial and other potential, including in meeting patients' and physicians' needs, improving treatment, helping patients achieve and sustain weight loss, improving health and quality of life and generating interest; future activities relating to lorcaserin, including submitting the BLOOM-DM results as a supplement to the NDA; lorcaserin's patent coverage; and Arena's strategy, research and development programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, regulatory authorities may not accept Arena's NDA submission; regulatory authorities may not find data from Arena's clinical trials and studies sufficient for regulatory approval; the timing, success and cost of Arena's lorcaserin program and other of its research and development programs; the timing and ability of Arena to receive regulatory approval for its drug candidates; results of clinical trials or preclinical studies may not be predictive of future results; clinical trials and studies may not proceed at the time or in the manner Arena expects or at all; Arena's ability to partner or commercialize lorcaserin or other of its compounds or programs; Arena's ability to obtain additional funds; Arena's ability to obtain and defend its patents; and the timing and receipt of payments and fees, if any, from Arena's collaborators. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Contact: Arena Pharmaceuticals, Inc. Media Contact: Russo Partners
Jack Lief David Schull, President President and CEO email@example.com 212.845.4271
SOURCE Arena Pharmaceuticals, Inc.
Posted: December 2009
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- Lorcaserin Receives Positive Vote From FDA Advisory Committee - May 10, 2012
- Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin - February 1, 2012
- FDA Accepts Resubmission of Lorcaserin New Drug Application - January 10, 2012
- Arena Submits Response to FDA Complete Response Letter for Lorcaserin - January 4, 2012
- Arena and Eisai Complete End-of-Review Meeting with FDA for Lorcaserin New Drug Application - December 22, 2010
- FDA Issues Complete Response Letter for Lorcaserin New Drug Application - October 25, 2010
- Arena and Eisai Provide Update on Lorcaserin FDA Advisory Committee Meeting - September 17, 2010
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- FDA Confirms September 16th Advisory Committee Meeting to Review Lorcaserin for Obesity and Weight Management - August 6, 2010
- Arena Pharmaceuticals Receives PDUFA Date for Lorcaserin NDA - February 26, 2010
- Arena Pharmaceuticals Announces FDA Acceptance of Lorcaserin NDA for Filing - February 24, 2010