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Janssen files sNDA for Xarelto to reduce risk of stent thrombosis in patients with ACS

Wednesday, May 09 2012 | Comments
Evidence Grade 0 What's This?
Janssen Research & Development LLC, a Johnson & Johnson company, filed a supplemental New Drug Application (sNDA) with the Food and Drug Administration seeking approval for Xarelto, an oral factor Xa inhibitor, to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS).

The FDA is currently reviewing a separate sNDA for Xarelto seeking approval of the anticoagulant to reduce the risk of secondary cardiovascular events in patients with ACS. The regulatory agency granted this application priority review status in February.

Both of these submissions were supported by data from the Phase III ATLAS ACS 2 TIMI 51 trial, findings from which were presented in November at the American Heart Association's annual meeting and were published in The New England Journal of Medicine.

The trial included more than 15,000 patients with a recent history of an ACS event. The participants were randomized to receive Xarelto 2.5 mg, Xarelto 5 mg or placebo twice daily in addition to standard care for as long as six months.

Xarelto successfully achieved the primary efficacy outcome measure by significantly reducing the rate of events in the composite endpoint--cardiovascular death, myocardial infarction and stroke--as compared with placebo.

In addition, the 2.5 mg twice-daily dose of Xarelto was associated with a statistically significant 35 percent reduction in the relative risk of stent thrombosis as compared with placebo. The rates of stent thrombosis in these groups were 2.2 percent and 2.9 percent, respectively.

The primary safety endpoint was major bleeding events not associated with coronary artery bypass graft surgery according to the Thrombolysis in Myocardial Infarction (TIMI) classification. The data for this endpoint indicated a statistically significant increase in such bleeding events with Xarelto 2.5 mg relative to placebo (1.8 percent vs. 0.6 percent, respectively), but this difference was not associated with an excess risk of fatal bleeding events.

In the United States, Xarelto is approved for the prophylaxis of deep vein thrombosis, which can lead to pulmonary embolism, in individuals who undergo knee or hip replacement surgery, and for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Earlier this month, Janssen submitted an sNDA for Xarelto seeking approval of the drug for the treatment and prevention of recurrent venous thromboembolism.

Janssen is developing Xarelto with Bayer HealthCare AG. Janssen Pharmaceuticals Inc. holds U.S. marketing rights to Xarelto.

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