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FDA denied ACS indication for rivaroxaban
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The FDA has opted not to approve rivaroxaban for the reduction of the risk for secondary CV events in patients with acute coronary syndrome, according to a press release from the drug manufacturer.
In May, the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 6-4, with one abstention, against approval of rivaroxaban (Xarelto, Janssen Pharmaceuticals) for use in ACS. Despite positive results from the global, phase 3 ATLAS ACS 2-TIMI 51 study, the panel members cited concerns about missing data on a large number of early patient withdrawals.
“We are confident in the robust study results of the ATLAS ACS 2-TIMI 51 trial and the positive benefit-risk profile of rivaroxaban in patients with ACS. We will continue to work with the FDA to fully address their questions as quickly as possible,” Paul Burton, MD, PhD, vice president, Cardiovascular Franchise Medical Leader, at Janssen, said in the release.
Rivaroxaban is already approved in the US for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery, and to reduce the risk for stroke and systemic embolism in patients with nonvalvular atrial fibrillation.