An FDA advisory panel left no room for interpretation Thursday as to whether it thought the FDA should approve Johnson & Johnson's ($JNJ) Xarelto (rivaroxaban) as a treatment for acute coronary syndrome (ACS), delivering its "no" loud and clear at the end of the daylong hearing.
Panel members voted nearly unanimously to reject the drug, tallying 10-0 against with one abstention. As Reuters reports, the committee said data from a sole clinical trial, the ATLAS program, were not enough to get the drug approved--especially in light of the fact that some of the trial data were missing. That doesn't look good for Xarelto's FDA prospects, and the agency has already turned the drug away twice for ACS.
Paul Burton, VP of clinical development for J&J's Janssen R&D segment, said in a statement that the company would work with the FDA to address questions raised at the meeting. "We appreciate the thoroughness of the committee's review and continue to believe rivaroxaban, in addition to the current standard of care, may help provide patients with ACS additional protection against life-threatening cardiovascular events such as death, heart attack and stroke," he said.
Clot-fighter Xarelto already has 6 indications in the U.S., including one for preventing stroke in patients with atrial fibrillation that put it in a head-to-head battle with Boehringer Ingelheim's Pradaxa. Sales aren't too shabby, either: The drug netted $347 million in U.S. sales in the first half of 2013, bringing in another €374 million outside the country for partner Bayer. That adds up to about $847 million, setting Xarelto up to pass the blockbuster benchmark in just its second full year on the market.
But the real prize, as far as the companies are concerned, is an indication for ACS, which hospitalizes 1.2 million patients annually. Xarelto is the only anticoagulant in its generation so far to have generated data strong enough to even warrant an application for FDA approval. But J&J is so far 0-for-2 on that front, with the agency's rejection coming in June of 2012 and then again last March.
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