News | April 12, 2013

FDA Seeks Additional Data in its Review of Xarelto

April 12, 2013 — The U.S. Food and Drug Administration (FDA) 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). Janssen Research and Development LLC is evaluating the letter and will respond to the agency's questions.

"We remain confident in the robustness and results of the ATLAS ACS 2 TIMI 51 trial, evidenced by a significant reduction in cardiovascular events, including a clinically important decrease in cardiovascular death, as published in the New England Journal of Medicine. While we saw an increase in major bleeding, there was no increase in fatal bleeding," said Christopher Nessel, vice president at Janssen. "We will continue to work with the FDA to address their questions."

On Feb. 27, 2012, Janssen received a priority review designation from the FDA regarding the sNDA for Xarelto for the reduction of the risk of cardiovascular events in patients with ACS, and on June 21, 2012, Janssen received a complete response letter for this sNDA. On Sept. 6, 2012, Janssen submitted to the FDA important data related to patients who had withdrawn from the ATLAS ACS 2 TIMI 51 trial (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with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.

To compile these data, the company undertook a global effort and was able to confirm the vital status information for 843, or 63 percent, of the 1,338 trial participants who previously had unknown vital status. The mortality benefit observed during the treatment phase of the study was maintained. These new events were distributed equally between the three treatment groups (2.5 mg, 5 mg and placebo) of patients who were alive (806) and those who had died (37). After these efforts, follow up data was not available on only 2.4 percent of patients.

The sNDA includes results from the 15,526-patient pivotal Phase 3 ATLAS ACS 2 TIMI 51 clinical trial of Xarelto which were presented at the American Heart Association (AHA) annual Scientific Sessions in November 2011 and simultaneously published by New England Journal of Medicine. It also contains data from the 3,491-patient Phase 2 ATLAS ACS 2 TIMI 46 clinical trial, which were presented at the American Heart Association (AHA) annual Scientific Sessions in November 2008 and published in The Lancet.

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.

Xarelto has the broadest indication profile of any of the newer oral anticoagulants in the U.S. market today and is approved for six clinical uses in the United States

For more information: www.xarelto-us.com

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