Orexigen Eyes Earlier Resubmission Of Contrave NDA
This article was originally published in Pharmaceutical Approvals Monthly
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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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.
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.
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.