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.