On Monday, the U.S. Food and Drug Administration announced it had rejected another drug application for Xarelto, the Johnson and Johnson indication for acute coronary syndrome (ACS). This is the second time the FDA has rejected Johnson & Johnson’s Xarelto.
The indication for Xarelto also referred to as rivaroxaban is for treating patients that suffer from ACS. Despite the pharmaceutical giant receiving much acclaim during 2011 after announcing the trial for ACS 2-TIMI 51, the treatment has ran into roadblocks from the Cardiovascular and Renal Drugs Committee of the FDA.
The drug has already been approved for preventing blood clots following hip and knee replacements, as well as in the prevention of blood clots for people who have atrial fibrillation and the prevention of strokes.
The proposed drug for ACS also showed significant signs of success following a priority review by the FDA in February of last year, but that was fleeting after reviewers from the FDA raised a concern over the trial. Because of that, the indication was rejected when voted upon by the committee.
In June of 2012, the company released a statement following the first rejection, saying they were still confident due to the strong results from the trial and Xarelto’s positive benefit versus risk profile in those patients suffering from ACS.
Johnson & Johnson remained staunch in its support for Xarelto this time as well. The company released a statement on Monday that summarized their continued support of the Xarelto, the ACS indication.