By Professor Juan Tamargo
The FDA’s Cardiovascular and Renal Drugs Advisory Committee declined to approve (6-4, with one abstention) to approve rivaroxaban for use in acute coronary syndromes (ACS).
Despite positive results from the global, phase III ATLAS ACS 2-TIMI 51 study, the panel members cited concerns about missing data on a large number of early patient withdrawals and deaths that had gone uncounted.
The ATLAS ACS 2-TIMI 51 trial is a randomized, double blind, placebo-controlled, event-driven study that enrolled 15,526 patients.
In this study rivaroxaban-combined doses were superior to placebo at reducing the risk for the primary efficacy endpoint of the composite of CV death, MI or stroke (HR=0.84; 95% CI, 0.74-0.96). However, patients assigned to 2.5 or 5.0 mg rivaroxaban bid had increased rates for non-CABG TIMI major bleeding versus placebo.
Rivaroxaban is already approved in the US for the prophylaxis of deep vein thrombosis in patients undergoing knee or hip replacement surgery, and to reduce the risk for stroke and systemic embolism in patients with nonvalvular atrial fibrillation.