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FDA Approves Rivaroxaban for CV Prevention in CAD, PAD

— Low dose to arrive in the U.S. next week

Last Updated October 18, 2018
Ƶ MedicalToday

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Rivaroxaban (Xarelto) was approved for another indication, this time the long-term prevention of major adverse cardiovascular events in people with coronary artery disease (CAD) and peripheral artery disease (PAD), Janssen announced in a .

This brings the 2.5 mg dose of the non-vitamin K antagonist oral anticoagulant to the U.S., where it is expected to hit pharmacy shelves on Oct. 19, the manufacturer said. The low dose had been made available in Europe in 2013 for the prevention of atherothrombotic events after an acute coronary syndrome (ACS) in high-risk adults.

The new indications for use in CAD and PAD were based on the COMPASS trial, in which rivaroxaban 2.5 mg twice daily plus aspirin prevented more cardiovascular deaths, strokes, and myocardial infarctions than aspirin alone in patients with stable atherosclerotic vascular disease.

Importantly, bleeding is a risk with rivaroxaban, a Factor Xa inhibitor. Because of this, an antidote for this class of drugs was cleared by the FDA this year (a broader commercial launch to come in early 2019).

The agency previously approved rivaroxaban for:

Janssen emphasized that rivaroxaban is not for people with artificial heart valves. The company recently acknowledged that rivaroxaban used after transcatheter aortic valve replacement was tied to more adverse events, pulling the plug on the GALILEO trial based on a preliminary analysis.

FDA previously rejected an indication for the drug in the prevention of stent thrombosis in ACS patients.

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    Nicole Lou is a reporter for Ƶ, where she covers cardiology news and other developments in medicine.