NBCA Applauds FDA Approval of New Drug to Reduce the Risk of Stroke, Blood Clots in Patients with Atrial Fibrillation

The National Blood Clot Alliance (NBCA) learned that the Food and Drug Administration (FDA) approved Eliquis (apixaban) for stroke and blood clot  prevention in patients with nonvalvular atrial fibrillation  (Afib).  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333634.htm

Jack Ansell, MD, Chair of NBCA’s Medical and Scientific Advisory Board (Chair, Department of Medicine, Lenox Hill Hospital, NY) said that “Eliquis demonstrated superiority over warfarin in reducing risks of stroke and blood clots, major bleeding and overall mortality for Afib  patients.”

NBCA’s President, Randy Fenninger said that “this drug has the potential of benefitting the 2.6 million patients in the U.S. who are diagnosed with Afib.” Fenninger added that “this represents an important additional option for patients with Afib because warfarin is often difficult for patients and doctors to manage.”

Eliquis is the third new oral anticoagulant to be approved in the last three years.  The first was dabigatran etexilate (Pradaxa, Boehringer Ingelheim Pharmaceuticals), and the second was rivaroxaban (Xarelto, Janssen Pharmaceuticals) which are now used by a growing number of individuals with Afib.  These new drugs have advantages over warfarin in that they do not require routine monitoring and their effect is not influenced by diet or many other drugs.  As a result, they are less burdensome for the patient to manage as well as for the doctor.

“Blood clots in the heart can cause a disabling stroke if the clots travel to the brain,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming.”

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.

Eliquis is manufactured Bristol-Myers Squibb Company of Princeton, N.J. and marketed by BMS and Pfizer Inc. of New York.

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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