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 investigational weight management drug, 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 comorbid 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, president and CEO of the manufacturer, Arena. “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 CEO of marketing partner Eisai Inc. “We look forward to the outcome of the lorcaserin new drug application discussions with the FDA.”