Advisory Committee Recommends Against Xarelto Approval

An FDA advisory committee recommended against the oral anticoagulant, which is intended to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome.

Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted against the approval of XARELTO (rivaroxaban), an oral anticoagulant, to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome (ACS) in combination with standard antiplatelet therapy.

'We appreciate the thoroughness of the committee's review, and will ensure the questions raised today are addressed with the FDA,' said Paul Burton, M.D., Ph.D., Vice President, Cardiovascular Franchise Medical Leader at Janssen.

XARELTO is approved in the U.S. to reduce the risk of blood clots in the legs and lungs of people who have just had knee or 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.

Data presented at today's advisory committee meeting included results from the pivotal Phase 3 ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome) clinical trial which compared rivaroxaban dosed twice daily (BID) in addition to standard therapy - low-dose aspirin with or without a thienopyridine such as clopidogrel - with standard therapy alone in the composite primary efficacy endpoint of cardiovascular-related deaths, heart attacks or strokes in patients with ACS.

Results from the ATLAS ACS 2 TIMI 51 study showed that rivaroxaban, given in combination with standard antiplatelet therapy was superior to standard therapy alone in preventing secondary cardiovascular events in patients with ACS. In patients receiving rivaroxaban and standard therapy, rates of TIMI major bleeding events not associated with coronary artery bypass graft (CABG) surgery were low overall, yet statistically significantly increased versus those treated with standard therapy plus a placebo. Importantly, these differences were not associated with an excess risk of fatal bleeding.

The FDA assigned a Priority Review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for rivaroxaban in patients with ACS. Recommendations from the advisory committee will be considered by the FDA in its review of the sNDA for rivaroxaban in this indication, but the FDA are not bound to follow them. If approved by the FDA, Janssen Pharmaceuticals, Inc. will commercialize rivaroxaban for this additional indication in the U.S.

About Acute Coronary Syndrome (ACS)

ACS is a complication of coronary heart disease, which is the leading cause of death in the U.S. and one of the most prevalent non-communicable diseases in the world. ACS occurs when a blood clot blocks a coronary artery, reducing blood supply to the heart. This disruption of blood flow can cause a heart attack, or unstable angina, a condition signifying that a heart attack may soon occur. Each year, an estimated 1.2 million patients in the U.S. are discharged from the hospital with a diagnosis of ACS.

About XARELTO (rivaroxaban)

XARELTO belongs to a group of medicines called anticoagulants, and works by blocking the blood clotting Factor Xa, thereby reducing the tendency to form clots. In the U.S., 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, 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. There is limited information on how XARELTO compares to a medicine called warfarin in reducing the risk of stroke when the blood levels of warfarin are well-controlled. The blood levels of warfarin often vary in patients.

The extensive program of clinical trials evaluating rivaroxaban makes the compound the most studied oral, Factor Xa inhibitor in the world today. Rivaroxaban is being developed jointly by Janssen Research & Development, LLC and Bayer HealthCare. U.S. marketing rights for XARELTO are held by Janssen Pharmaceuticals, Inc.

Source: 2012 Electronic News Publishing

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