Johnson & Johnson JNJ – said today that it had received a complete response letter from the FDA for the supplemental new drug application for rivaroxaban (Xarrelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the general use of rivaroxaban to treat ACS patients.
Both sNDAs were based on the pivotal ATLAS ACS 2-TIMI 51 trial. Initially the trial was widely praised, leading to expectations that rivaroxaban would be the first anticoagulant to receive an ACS-related indication. But the enthusiasm evaporated when FDA reviewers raised concerns about the trial and when the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against the ACS indication. (Diverging from their US colleagues, European regulators granted the general ACS indication for rivaroxaban in May.)