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US FDA advisory panel rejects Janssen's oral anticoagulant Xarelto for acute coronary syndrome

New Jersey
Saturday, January 18, 2014, 09:00 Hrs  [IST]

The US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted against the approval of the use of Janssen Research & Development's Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS) in combination with standard antiplatelet therapy. Janssen is seeking approval of rivaroxaban at a proposed dose of 2.5 mg twice daily (BID) for a 90 day treatment duration.

"We appreciate the thoroughness of the committee's review and continue to believe rivaroxaban, in addition to the current standard of care, may help provide patients with ACS additional protection against life-threatening cardiovascular events such as death, heart attack and stroke," said Paul Burton,vice president, clinical development, Janssen Research & Development. "We will work with the FDA to address questions raised today."

The advisory committee's recommendation was based on review of the 15,526-patient pivotal phase III 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 of rivaroxaban.

In August 2013, Janssen issued a resubmission to the complete response from the FDA for rivaroxaban 2.5 mg twice daily (BID) to reduce the risk of secondary cardiovascular events in patients with ACS for a 90 day treatment duration. Recommendations from the advisory committee today will be considered by the FDA in its review of the supplemental New Drug Application (sNDA) for rivaroxaban in this indication, but the recommendation of the advisory committee panel is not binding. If approved by the FDA, rivaroxaban will be commercialized for this additional indication in the US by Janssen Pharmaceuticals, Inc.

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 Thrombolysis In Myocardial Infarction (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.

Janssen is 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.

 

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