NBCA Applauds FDA Approval of Xarelto toTreat DVT/PE

NBCA Applauds FDA Approval of Xarelto toTreat DVT/PE

Tarrytown, NY November 2, 2012  – The National Blood Clot Alliance (NBCA) learned today, that the Food and Drug Administration (FDA) approved Xarelto (rivaroxaban) for treating deep vein thrombosis (DVT) and pulmonary embolism (PE).  FDA’s approval also includes using Xarelto to prevent recurrence of DVT and PE after treatment.  Jack Ansell, MD, Chair of NBCA’s Medical and Scientific Advisory Board (Chair, Department of Medicine, Lenox Hill Hospital, NY) said that “DVTs and PEs are associated with a high risk of serious complications” and “this drug provides a single drug treatment option from the moment of diagnosis through the completion of therapy.” Dr. Ansell pointed out that Xarelto “can cut a patient’s risk of major bleeding by nearly half.”  FDA’s approval “will immediately impact how we treat these patients and may set a new standard of care,” Ansell added.

NBCA’s President, Randy Fenninger said that “this new drug has the potential of benefitting many of the hundreds of thousands of patients in the U.S. who experience blood clots every year.”  Fenninger added that “the added benefit of reducing the risk of recurring blood clots provides great comfort to those who have experienced the pain, discomfort and life-threatening impact of a DVT and/or PE.”

Blood clots occur when blood thickens and clumps together. DVT (deep vein thrombosis) is the formation of a blood clot in a deep vein which commonly affects the leg veins or the deep veins in the pelvis. PE (pulmonary embolism) is a potentially deadly blockage of the main artery of the lung or one of its branches by a clot that has travelled from elsewhere in the body through the bloodstream.

“Xarelto is the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since the approval of warfarin nearly 60 years ago,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm326654.htm

Other drugs approved by FDA to treat or reduce the risk of blood clots include Lovenox (enoxaparin), generic versions of enoxaparin, Arixtra (fondaparinux), Fragmin (dalteparin), Coumadin (warfarin), and heparin.

Xarelto is already FDA-approved to reduce the risk of DVTs and PEs from occurring after knee or hip replacement surgery (July 2011), and to reduce the risk of stroke in people who have a type of abnormal heart rhythm called non-valvular atrial fibrillation (November 2011).

Xarelto is marketed by Raritan, N.J.-based Janssen Pharmaceuticals Inc.

The National Blood Clot Alliance’s mission is to advance prevention, early diagnosis and successful treatment of blood clots, clotting disorders and clot-provoked strokes through public awareness, advocacy and patient and professional education.

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