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Arena Pharma Gets Complete Response Letter For Lorcaserin New Drug Application

Arena Pharmaceuticals Inc. (ARNA) and Eisai Inc. announced that the US Food and Drug Administration issued a Complete Response Letter regarding Arena's New Drug Application for lorcaserin. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese or patients who are overweightand have at least one weight-related co-morbid condition.

The FDA has completed its review of the NDA and determined that it cannot approve the application in its present form. In the CRL, the FDA outlined the non-clinical and clinical reasons for their decision.

The non-clinical issues identified by the FDA included diagnostic uncertainty in the classification of mammary masses in female rats, unresolved exposure-response relationship for lorcaserin-emergent mammary adenocarcinoma, and unidentified mode of action and unclear safety margin for lorcaserin-emergent brain astrocytoma.

Arena intends to request a Type A meeting with the FDA to clarify its requests, and, if the meeting is granted, the FDA's guidance states that it should occur within 30 days of the request.

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