Janssen Research & Development Submits Complete Response To The U.S. FDA on XARELTO® (rivaroxaban) for the Reduction Of Secondary Cardiovascular Events In Patients With Acute Coronary Syndrome

Supplemental New Drug Application for XARELTO® to reduce the risk of stent thrombosis
in patients with acute coronary syndrome also resubmitted

Raritan, NJ (September 7, 2012) — Janssen Research & Development, LLC (Janssen) announced today that it has submitted the Complete Response to the U.S. Food and Drug Administration (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.


“We are confident in the results of the ATLAS ACS 2 TIMI 51 trial and have relied on the data from that study to develop our comprehensive responses to questions raised by the FDA in their review of our application,” said Paul Burton, M.D., Ph.D., Vice President at Janssen R&D. “We look forward to working with the agency to make XARELTO® available to patients who experience a heart attack and need treatment to reduce the risk of another heart attack, a blocked coronary stent or death.”

XARELTO® is approved for three clinical uses in the U.S.: 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.

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.

Coronary stents are implanted in more than 1.5 million patients each year. Stent thrombosis is uncommon, but may result in a catastrophic complication after a stent has been inserted into a patient’s coronary artery. Stent thrombosis can result in a heart attack or even death.


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. 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. 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.

XARELTO® has the broadest profile of any of the newer oral anticoagulants either in market today or coming to the U.S. market in the foreseeable future, and is broadly available for more than 90% of commercial and Medicare health plan members. To date, more than 1.5 million patients have received XARELTO® worldwide and more than 500,000 prescriptions have been written for XARELTO® in the U.S. alone.

The extensive program of clinical trials evaluating rivaroxaban makes the compound the most studied oral, Factor Xa inhibitor in the world today. By the time of its completion, more than 75,000 patients will have participated in the rivaroxaban clinical development program. There are five filings currently under review at the FDA. Rivaroxaban is being developed jointly by Janssen and Bayer HealthCare. U.S. marketing rights for XARELTO® are held by Janssen Pharmaceuticals, Inc.


About Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.