Bristol-Myers Squibb and Pfizer Announce U.S. FDA Approval of ELIQUIS® (apixaban)
Friday, December 28, 2012 5:46 pm EST
Please see full Prescribing Information including BOXED WARNING and Medication Guide available at www.bms.com.
Here is the FDA Press Release:
FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation
The U.S. Food and Drug Administration today approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
Atrial fibrillation, one of the most common types of abnormal heart rhythm, is an abnormal, irregular, and rapid beating of the heart in which the heart’s two upper chambers (atria) do not contract properly, allowing blood clots to form in them. These clots can break off and travel to the brain or other parts of the body.
“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.”
The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by cardiac valve disease were studied in a clinical trial of more than 18,000 patients that compared Eliquis with the anti-clotting drug warfarin. In the trial, patients taking Eliquis had fewer strokes than those who took warfarin.
Patients with prosthetic heart valves should not take Eliquis nor should patients with atrial fibrillation that is caused by a heart valve problem. These patients were not studied in clinical trial. As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with Eliquis. There is no agent that can reverse the anti-coagulant effect of Eliquis.
Eliquis will be dispensed with a patient Medication Guide that provides instructions on its use and drug safety information. Health care professionals should counsel patients on signs and symptoms of possible bleeding.
Eliquis is manufactured Bristol-Myers Squibb Company of Princeton, N.J. and marketed by BMS and Pfizer Inc. of New York.
Comment: Someone just asked “how is apixaban better than warfarin?” My reply: “No food or drug interactions, no blood draws for INR tests (works by a different mechanism from warfarin), better protection from strokes, and fewer brain bleeds (intracranial hemorrhage). Note that apixaban has two downsides: higher cost and lack of a reversal agent. However, warfarin is not instantly reversible either, and has a much longer “half-life” in the body than apixaban. Here’s an article providing more background: Apixaban Superior to Warfarin for Atrial Fibrillation Stroke Prevention”