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Arena Pharmaceuticals, Inc. (ARNA) Responds to FDA Worries About Antiobesity Drug


1/4/2012 8:25:22 AM

Arena Pharmaceuticals and partner Eisai are hopeful regulators will look kindly on its obesity drug lorcaserin after responding to a rejection issued by the US Food and Drug Administration in October 2010. Arena has submitted its reply to the complete response letter from the FDA which cited a number of reasons for its decision, notably concerns about tumours found in animal studies. The response includes data and analyses that were not incorporated in the original New Drug Application, including the results of the Phase III BLOOM-DM trial, which evaluated lorcaserin for weight loss in patients with type 2 diabetes.

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