FDA Issues Second Complete Response Letter to sNDA for Xarelto
Janssen Research & Development announced that the FDA has issued a second complete response letter regarding a supplemental New Drug Application (sNDA) for Xarelto (rivaroxaban) for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome (ACS). Xarelto works by blocking the blood clotting Factor Xa.
The sNDA included results from the 15,526-patient pivotal Phase 3 ATLAS ACS 2 TIMI 51 clinical trial and data from the 3,491-patient Phase 2 ATLAS ACS 2 TIMI 46 clinical trial. Previously Janssen submitted important data to the FDA regarding patients who had withdrawn from the ATLAS ACS 2 TIMI 51 trial (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome) as part of its complete response.
Xarelto is indicated to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery, to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by heart valve problem, to treat people with pulmonary embolism (PE) or deep vein thrombosis (DVT), and to reduce the risk or recurrence of DVT or PE following an initial six months of treatment for acute venous thromboembolism.
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