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news.The US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee has voted 9 to 5 that the available data do not adequately demonstrate that the benefits of Eisai's Lorcaserin outweigh the risks, when used long-term in a population of overweight and obese individuals to allow marketing approval.
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Lorcaserin is the subject of an exclusive licensing agreement concluded between Eisai’s US subsidiary Eisai Inc and Arena Pharmaceuticals GmbH, the wholly-owned Swiss subsidiary of Arena Pharmaceuticals Inc, concerning its commercialisation in the US.
Lorcaserin, discovered and developed by Arena, is indicated for weight management, including weight loss and maintenance of weight loss, in patients who are obese or patients who are overweight and have at least one weight-related co-morbid condition.
Arena is expected to continue to work with the FDA as it completes review of the Lorcaserin new drug application.
The PDUFA date, the target date for the agency to complete its review of the Lorcaserin new drug application (NDA), given by the FDA is 22 October 2010.