With SPA Finalized, Orexigen To Begin CV Outcomes Study For Contrave In Second Quarter
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
Use Of Pre-Approval CV Data From Ongoing Trial Gets Once-Over At Canagliflozin Panel
There is no statistical reason not to allow a single trial to provide pre-approval and post-approval cardiovascular hazard ratios for a diabetes drug, FDA says, but Janssen’s canagliflozin would be the first. The Endocrinologic and Metabolic Drugs Advisory Committee backed approval 10-5.
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.
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.