Arena Pharmaceuticals Inc., a clinical-stage biopharmaceutical company, has filed Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for lorcaserin, an investigational drug candidate intended for weight control, including weight loss and maintenance of weight loss, in patients who are obese (BMI > 30) or patients who are overweight (BMI > 27) and have at least one weight-related co-morbid condition.
Arena expects the EMA will accept the filing later this month and confirm the filing is sufficiently complete to permit a substantive review.
“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 CEO. “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 EU member countries.”
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 US 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. 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.
Arena is 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.