BelviqTreatment for Obesity
Update: Belviq (lorcaserin) Now FDA Approved - June 27, 2012
FDA Accepts Lorcaserin NDA
Arena Pharmaceuticals Announces FDA Acceptance of Lorcaserin NDA for Filing
SAN DIEGO, Feb. 24, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. announced today that its New Drug Application (NDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss, has been accepted for filing by the US Food and Drug Administration (FDA). Arena submitted the lorcaserin NDA on December 22, 2009, and expects to learn the Prescription Drug User Fee Act (PDUFA) date in the next few weeks. The PDUFA date is the target date for the FDA to complete its review of an NDA.
"The FDA's acceptance of the lorcaserin NDA is a significant milestone towards our goal of providing physicians and their patients with a new mechanistic approach to achieve sustainable weight loss in a well-tolerated manner," said Jack Lief, Arena's President and Chief Executive Officer. "We look forward to working with the FDA to facilitate a thoughtful and efficient review of the lorcaserin NDA."
The NDA is based on a data package from lorcaserin's development program that includes 18 clinical trials totaling 8,576 patients. 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. In both trials, lorcaserin produced statistically significant weight loss with excellent safety and tolerability.
Phase 3 Program Overview
BLOOM and BLOSSOM comprise the pivotal Phase 3 program and are the basis of the lorcaserin NDA. These double-blind, randomized, placebo-controlled trials evaluated 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. Arena plans to file the results of BLOOM-DM 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's most advanced drug candidate, lorcaserin, is intended for weight management, including weight loss and maintenance of weight loss, and has completed a pivotal Phase 3 clinical trial program. Arena submitted an NDA for lorcaserin to the FDA in December 2009, and the FDA has accepted the NDA for filing.
Arena Pharmaceuticals® and Arena® 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 review and approval of lorcaserin; the significance of the FDA's acceptance of the lorcaserin NDA for filing; lorcaserin's commercial and other potential, including in providing a new approach to achieve weight loss; future activities and events relating to lorcaserin, including the receipt of a PDUFA date, working with the FDA in the regulatory review process and submitting the BLOOM-DM results as a supplement to the NDA; lorcaserin's patent coverage; and Arena's goals, 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 find data from Arena's clinical trials and other studies sufficient for regulatory approval; the timing and ability of Arena to receive regulatory approval for its drug candidates; the timing, success and cost of Arena's lorcaserin program and other of its research and development programs; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other 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 adequate 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.
Source: Arena Pharmaceuticals, Inc.
CONTACT: Jack Lief, President and CEO, or Cindy McGee, Manager, IR and
Corporate Communications, +1-858-453-7200, ext. 1479, firstname.lastname@example.org,
both of Arena Pharmaceuticals, Inc.; or David Schull, President,
+1-212-845-4271, email@example.com, or Anthony J. Russo,
Ph.D., CEO, +1-212-845-4251, firstname.lastname@example.org, both of Russo
Partners, for Arena Pharmaceuticals, Inc.
Web Site: http://www.arenapharm.com/
Posted: February 2010
- FDA Approves Belviq to Treat Some Overweight or Obese Adults - June 27, 2012
- 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
- Obesity Expert to Speak to FDA in Support of Treatment Options for Obese Patients - September 15, 2010
- 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 Submits New Drug Application to FDA for Lorcaserin for Weight Management - December 22, 2009