Arena Pharmaceuticals Files European Marketing Authorization Application for Lorcaserin for Weight Control
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"With rates of obesity tripling in many European countries over the last thirty years, there is a substantial unmet need for new treatments to manage weight," said Jack Lief, Arena's President and Chief Executive Officer. "We look forward to working with the EMA and our Rapporteur and Co-rapporteur during this centralized review process and to the potential approval of lorcaserin in E.U. member countries."
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 believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States, major European countries and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
Arena resubmitted to the U.S. Food and Drug Administration (FDA) the lorcaserin New Drug Application (NDA) in December 2011, and the agency assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012. Eisai Inc. has exclusive rights to market and distribute lorcaserin in the United States subject to FDA approval of the lorcaserin NDA. Arena currently owns rights to lorcaserin outside of the United States.