Pharmabiz
 

US FDA committee recommends approval of Lorcaserin

San DiegoSaturday, May 12, 2012, 09:00 Hrs  [IST]

Arena Pharmaceuticals, Inc. and Eisai Inc. have received positive votes the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, that the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals.

Lorcaserin is an investigational drug candidate intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI greater than or equal to 30) or patients who are overweight (BMI greater than or equal to 27) and have at least one weight-related co-morbid condition.

“The advisory committee's positive vote supports our belief in lorcaserin as a potential new treatment option for the medical management of overweight and obesity,” said Jack Lief, Arena's president and chief executive officer. “We will continue to work with the FDA as the agency completes its review of the lorcaserin new drug application.”

Although advisory committees provide recommendations to the FDA, the agency makes the final decisions. The Prescription Drug User Fee Act (PDUFA) date for the lorcaserin New Drug Application (NDA) resubmission is June 27, 2012, which is the target date for the agency to complete its review.

“Eisai's commitment to advancing innovative therapies in areas of medical need continues to be a cornerstone of our corporate mission,” stated Lonnel Coats, president and chief executive officer, Eisai Inc. “We look forward to the outcome of the lorcaserin new drug application discussions with the FDA.”

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, Europe 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 submitted the original NDA for lorcaserin to the FDA in December 2009, and the agency issued a Complete Response Letter (CRL) in October 2010. Arena resubmitted the lorcaserin NDA to the FDA in December 2011, and the agency assigned a 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. In addition, the European Medicines Agency accepted the lorcaserin marketing authorization application for filing in March 2012.

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.

Eisai Inc. focus includes neurology, gastrointestinal disorders and oncology/critical care.

























Arena Pharmaceuticals, Inc. and Eisai Inc. have received positive votes the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, that the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals.

Lorcaserin is an investigational drug candidate intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI greater than or equal to 30) or patients who are overweight (BMI greater than or equal to 27) and have at least one weight-related co-morbid condition.

“The advisory committee's positive vote supports our belief in lorcaserin as a potential new treatment option for the medical management of overweight and obesity,” said Jack Lief, Arena's president and chief executive officer. “We will continue to work with the FDA as the agency completes its review of the lorcaserin new drug application.”

Although advisory committees provide recommendations to the FDA, the agency makes the final decisions. The Prescription Drug User Fee Act (PDUFA) date for the lorcaserin New Drug Application (NDA) resubmission is June 27, 2012, which is the target date for the agency to complete its review.

“Eisai's commitment to advancing innovative therapies in areas of medical need continues to be a cornerstone of our corporate mission,” stated Lonnel Coats, president and chief executive officer, Eisai Inc. “We look forward to the outcome of the lorcaserin new drug application discussions with the FDA.”

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, Europe 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 submitted the original NDA for lorcaserin to the FDA in December 2009, and the agency issued a Complete Response Letter (CRL) in October 2010. Arena resubmitted the lorcaserin NDA to the FDA in December 2011, and the agency assigned a 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. In addition, the European Medicines Agency accepted the lorcaserin marketing authorization application for filing in March 2012.

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.

Eisai Inc. focus includes neurology, gastrointestinal disorders and oncology/critical care.

 
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