Company says it plans to file for new approval of anticoagulant by year end.

A Phase III study evaluating Janssen’s Xarelto (oral rivaroxaban) in patients with acute coronary syndrome (ACS) demonstrated that adding the drug to standard therapy significantly reduced the composite primary efficacy endpoint of cardiovascular-related deaths, heart attacks, or stroke. The firm says it plans to submit the data to FDA for review before year-end.

ATLAS ACS 2 TIMI 51 evaluated the use of either rivaroxaban or placebo, in addition to standard antiplatelet therapy (low-dose aspirin with or without a thienopyridine) in 15,526 patients with ACS. Rivaroxaban-treated patients received either 2.5 mg or 5 mg of the drug twice daily. The results, reported by Janssen’s Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), showed that compared with placebo plus standard therapy, rivaroxaban plus standard therapy reduced the risk of cardiovascular events by 16% over and above that of placebo plus standard therapy.

The twice-daily 2.5 mg dose of rivaroxaban reduced the rates of death from cardiovascular causes by 34% compared with placebo plus standard therapy (2.7% vs. 4.1%), and also reduced the risk of death from any cause by 32% (2.9% vs. 4.5%), but the survival benefit wasn’t seen with the twice-daily 5 mg dose. Rivaroxaban did increase the risk of major bleeding and intracranial hemorrhage, but not the risk of fatal bleeding.

Data from the pivotal Phase III ATLAS ACS 2 TIMI 51 study is reported just a week after FDA approved Xarelto for the new indication of reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

The ATLAS ACS 2 TIMI 51 data was presented at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine in a paper titled “Rivaroxaban in Patients with a Recent Acute Coronary Syndrome.”

J&JPRD is developing rivaroxabain in collaboration with Bayer HealthCare for a range of disorders characterized by blood clotting. 

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