Orexigen Agreement On Contrave CV Trial Hints At FDA’s Thinking On Obesity
Executive Summary
FDA appears to be testing weight loss agents against an easier-to-meet threshold for cardiovascular risk compared to diabetes drugs, based on Orexigen Therapeutics Inc.’s announcement of an agreement with the agency on a cardiovascular outcomes trial for its obesity agent Contrave (naltrexone/bupropion).
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Orexigen Eyes Earlier Resubmission Of Contrave NDA
The company is optimistic it can work out an agreement with FDA to re-file the obesity drug application before it has interim data from a cardiovascular outcomes trial in hand.