Additional Data Submitted for FDA’s Review of Rivaroxban for ACS

Janssen responds to FDA request for more information on the blood-thinning drug


September 13, 2012

September 13, 2012 — Janssen Research & Development LLC announced 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 United States: 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 United States 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 United States 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.

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.

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