Posts tagged ‘XARELTO’

XARELTO Advisory Committee Follow-up

Yesterday, the FDA’s Advisory Committee voted 9-2 in favor for recommending approval for XARELTO.  This is a remarkable outcome considering the very negative Briefing Document released by the FDA in advance of the meeting.  Let me rephrase that, it was not just a very negative Briefing Document but probably the most negative Briefing Document I’ve ever seen.  The J&J team must be congratulated.

But, how could the FDA interpretation of the data be so different from that of the sponsor, their advisors and the Advisory Committee members?  With such a positive vote by the Advisory Committee and such a negative review by the FDA, somebody seems to have gotten it very wrong.  At the 4,000 ft level, there appears to be a clue.  The overtone of the FDA review can be seen to have the flavor of “in a perfect world” while the contrary view of the sponsor and their experts emphasizes the “real world” experience of treating these patients.  Does this sound familiar?  To me it sounds like the same debate the 535 perfect-worlders in the principality of the US Congress are having with the real-worlders who elected them.

 

The approval of XARELTO for this indication is ultimately still in the hands of the FDA and they will make their decision on their view of the benefit/risk of this product and the ability of the sponsor to provide adequate labeling for its safe and effective use.

XARELTO (rivaroxaban) Advisory Committee Meeting

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.