Orexigen Eyes Earlier Resubmission Of Contrave NDA
This article was originally published in The Pink Sheet Daily
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.
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As a reviewer, team leader and deputy director in the Division of Metabolism and Endocrinology Products, Colman spearheaded the agency’s policy development on weight-management products.
More companies are turning to CDER’s formal appeals process when presented with a review division’s regulatory decision or advice. Even though few appeals are granted in full, many sponsors get valuable clarity on a path forward; some appeals, like that for Amarin’s Vascepa SPA, are turned away at the door.
The summary report of an interim analysis of the ongoing LIGHT clinical trial evaluating the cardiovascular safety of the obesity medicine can form the basis of a resubmission of the Contrave NDA, the company announced, shaving some time off the PDUFA clock.