Complete Response Submitted, sNDA Resubmitted for Xarelto for Acute Coronary Syndrome

Janssen Research & Development announced today that it has submitted the Complete Response to the FDA for the use of Xarelto (rivaroxaban) to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS). The response includes specific information requested by the FDA in their letter issued to Janssen on June 21, 2012.

Janssen also has resubmitted the supplemental New Drug Application (sNDA) for Xarelto to reduce the risk of stent thrombosis in patients with ACS, which the company withdrew on July 9, 2012 based on its connection to the above mentioned sNDA for Xarelto. Data from the ATLAS ACS 2 TIMI 51 trial support both sNDAs.

Xarelto is an anticoagulant that works by blocking the blood clotting Factor Xa, thereby reducing the tendency to form clots. Xarelto is approved for three uses: to reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery, to reduce this risk in people who have just had hip replacement surgery, and to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem.

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