FDA Confirms September 16th Advisory Committee Meeting To Review Lorcaserin For Obesity And Weight Management

Aug 8th, 2010 | By healthnews | Category: Health

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 08 Aug 2010 – 1:00 PDT

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Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced that the US Food and Drug Administration (FDA) has notified the company of the confirmed scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin New Drug Application (NDA). Lorcaserin, which Arena discovered and has developed for weight management, is intended for obese patients as well as overweight patients who have at least one weight-related co-morbid condition.

“Our primary objective at this time is to obtain FDA approval of lorcaserin,” said Jack Lief, Arena’s President and Chief Executive Officer. “We have been preparing for this anticipated Advisory Committee meeting, and look forward to reviewing lorcaserin’s profile with the panel members.”

Arena submitted the lorcaserin NDA on December 22, 2009, and the FDA assigned a PDUFA date, the target date for the agency to complete its review of the application, of October 22, 2010.

Lorcaserin New Drug Application

The lorcaserin New Drug Application 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 was well tolerated and produced statistically significant weight loss.

About Lorcaserin

Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of the serotonin 2C receptor in the hypothalamus is associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the United States 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.

Forward-Looking Statements

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 advancement, therapeutic indication and use, safety, efficacy, tolerability, and regulatory review and approval of lorcaserin; lorcaserin’s patent coverage; activities related to September 16, 2010 FDA advisory committee meeting; and Arena’s focus, objectives, 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, risks related to the implementation and continuation of the marketing and supply agreement with Eisai and dependence on Eisai for commercialization of lorcaserin in the United States; regulatory authorities or advisors 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 ability to enter into agreements to develop or commercialize lorcaserin and other of Arena’s compounds or programs; Arena’s ability to commercialize lorcaserin outside of the United States with another company or independently; the timing, success and cost of the lorcaserin program and other of Arena’s 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 or others expect or at all; 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 Eisai and 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



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