The application for XARELTO (revaroxaban), the J&J drug that was developed for it’s anti-clotting properties in preventing strokes is to be reviewed by the FDA CardioRenal Drug Advisory Committee on Thursday, Sept 9, 2011. Those interested in the FDA view of the application need read no further than the summary of the FDA Briefing Document to learn that the FDA Medical team has significant reservations on both the safety and the efficacy of this drug. How significant you ask? So significant that if I were advising the company, I’d tell them to cancel the Advisory Committee meeting. The FDA review started with a comment about readiness to issue a Complete Response Letter, that’s how serious! The FDA review has requested at least one additional study, that’s how serious. The FDA has said that any drug that expects to compete with Warfarin in these patients better be as good as Warfarin, that’s how serious. It looks like the FDA thinks that XARELTO performs at less than 70% of the efficacy of Warfarin.
Posts tagged ‘revaroxaban’