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Orexigen Eyes Earlier Resubmission Of Contrave NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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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Orexigen On Quicker-Than-Expected Pace To Obtain Data Needed To Re-File NDA For Contrave

During its second quarter earnings call, the biotech said it sees recent FDA approvals of two other obesity drugs as a positive for its own prospects, but it is re-engaging with the agency on why it must perform a cardiovascular-outcomes trial prior to approval.

CV Risk Assessment For All Obesity Drugs Seems Inevitable Pre-Approval Requirement

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee March 29 voted 17-6 that all obesity drugs should be vetted for cardiovascular risk, but some could rely on a meta-analysis rather than an outcomes trial.

With SPA Finalized, Orexigen To Begin CV Outcomes Study For Contrave In Second Quarter

The company expects to be able to re-file the NDA for its obesity candidate by 2014, after 87 major adverse events were recorded in the 10,000-patient, placebo-controlled safety trial.

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