FDA gives nod to Janssen for new indication for Xarelto
The Janssen Pharmaceutical Companies has received clearance from the Food and Drug Administration for Xarelto (rivaroxaban) to reduce the risk of major cardiovascular events, such as CV death, myocardial infarction and stroke, in people with chronic coronary or peripheral artery disease.
Xarelto is now the first and only Factor Xa inhibitor approved for patients living with these conditions, according to the company.
Chronic CAD and PAD occur when arteries become hardened or narrowed due to a buildup of cholesterol and plaque, potentially limiting blood flow to parts of the body. Known as atherosclerosis, this disease is rarely fatal, but is the most frequent underlying cause of chronic CAD and PAD, which affect 16.5 million and 10 million Americans, respectively.
Xarelto is now the first and only Factor Xa inhibitor approved for patients living with these conditions, according to the company.
Chronic CAD and PAD occur when arteries become hardened or narrowed due to a buildup of cholesterol and plaque, potentially limiting blood flow to parts of the body. Known as atherosclerosis, this disease is rarely fatal, but is the most frequent underlying cause of chronic CAD and PAD, which affect 16.5 million and 10 million Americans, respectively.