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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:

• Reduction of stroke and blood clots in people with non-valvular atrial fibrillation

• Treatment of deep vein thrombosis or pulmonary embolism and lowering the risk of recurrence
• Prevention of blood clots in people getting knee or hip replacement surgery

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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