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J&J's Xarelto gets US FDA approval to lower risk of serious heart problems

Johnson & Johnson said the U.S. Food and Drug Administration approved its blood thinning drug Xarelto, in combination with Aspirin, to lower the risk of serious heart problems, including heart attack and stroke.

The drug combination was approved for patients with coronary artery disease, or CAD, a condition where the blood supply to the heart is reduced or blocked; and peripheral arterial disease, or PAD, which is characterized by reduced blood flow to the legs.

CAD and PAD, which affect 16.5 million and 10 million Americans, respectively, arise when arteries become hardened or narrowed due to a buildup of cholesterol and plaque, potentially limiting blood flow to parts of the body.

Xarelto was previously approved to reduce the risk of blood clots in the veins of legs or lungs as well as among patients with atrial fibrillation, a condition involving irregular heart rate, that is not caused by a heart valve problem.

The latest approval is based on a phase 3 study, named Compass, which showed that the Xarelto-aspirin combination cut the risk of major heart-related problems by 24%.

The combination has already received approval in the European Union for similar treatment usage.

Xarelto, which is jointly developed by Johnson and Johnson and Germany-based Bayer AG, has now become the only Factor Xa inhibitor approved for treating coronary artery disease and peripheral arterial disease, the company said in an Oct. 11 news release.