February 14th, 2014

FDA Once Again Rejects New Indication For Rivaroxaban

The third time wasn’t the charm. The FDA today turned turned down — for the third time — the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke, or death. In addition, the FDA — for the second time — turned down the sNDA for rivaroxaban in the same population for the reduction of stent thrombosis.

The complete response letters come as little surprise, since an FDA advisory panel last month strongly recommended against approval for the indications. The large amount of missing data from the pivotal ATLAS ACS 2-TIMI 51 trial has been the source of the company’s inability to gain the ACS indications. Although J&J has made considerable efforts to fill in the missing data, the FDA reviewers and panel members did not believe the data were reliable enough to reach firm conclusions about the relative safety and efficacy of rivaroxaban for use in ACS.

“We remain committed to providing patients who have suffered from acute coronary syndrome with additional protection against stent thrombosis and secondary life-threatening cardiovascular events,” said a J&J executive in a statement. “We are evaluating the contents of the letters and will determine the appropriate next steps.”

FDA Rescinds Xarelto REMS

In a separate development, the FDA has rescinded the Xarelto REMS (Risk Evalaution and Mitigation Strategy). The company had been required to communicate the risks of an increased risk of thrombotic events when the drug was discontinued without an adequate alternative anticoagulant and was of decreased efficacy when not taken with the evening meal.


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