Xarelto Maker Seeks Indication for Acute Coronary Syndrome

Janssen Research & Development has submitted an application to the FDA requesting approval of Xarelto (rivaroxaban) to decrease the risk of thrombotic cardiovascular events in patients with acute coronary syndrome.

Janssen Research & Development, LLC announced late last month that it had submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration requesting approval of Xarelto (rivaroxaban) to decrease the risk of thrombotic cardiovascular events in patients with acute coronary syndrome, according to a press release.

Xarelto is an oral anticoagulant that reduces the chance of blood clot formation by inhibiting the blood clotting Factor Xa. It is currently approved in the US for prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in people undergoing knee or hip replacement surgery; it is also indicated for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

JRD hopes to win approval for the new indication based on data from the Phase 3 Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome (ATLAS ACS 2 TIMI 51) trial, which was presented in November at the American Heart Association Scientific Sessions. The study was then published in the New England Journal of Medicine.