News | March 12, 2014

FDA Issues Complete Response Letters for Use of Rivaroxaban to Reduce Secondary Cardiovascular Events

March 12, 2014 — Janssen Research and Development LLC (Janssen) announced the U.S. Food and Drug Administration (FDA) issued complete response letters (CRLs) regarding supplemental New Drug Applications (sNDAs) for the use of rivaroxaban (Xarelto), an oral anticoagulant, to reduce the risk of secondary cardiovascular events — defined as heart attack, stroke or death — in patients with acute coronary syndrome (ACS) and to reduce the risk of stent thrombosis in the same population, in combination with standard antiplatelet therapy.

"We remain committed to providing patients who have suffered from acute coronary syndrome with additional protection against stent thrombosis and secondary life-threatening cardiovascular events," said Paul Burton, M.D., Ph.D., vice president, clinical development, Janssen Research and Development. "We are evaluating the contents of the letters and will determine the appropriate next steps."

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. About 785,000 Americans have a first heart attack each year, while another 470,000 who have already experienced one or more heart attacks go on to have another attack.

Stent thrombosis is an uncommon, but potentially catastrophic complication that may occur after a stent has been inserted into a patient's coronary artery and causes clots to form. If blood flow is significantly restricted or completely blocked, this can result in unstable angina, myocardial infarction or even death, with incident rates as high as 64 percent. Survivors of a stent thrombosis event are at an elevated risk of recurrent stent thrombosis.

Both sNDAs are based on results from the 15,526-patient 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 CoronarySyndrome) clinical trial of rivaroxaban, which was presented at the American Heart Association's annual Scientific Sessions and published in the New England Journal of Medicine in November 2011.

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