German pharmaceutical giant Boehringer-Ingelheim got some very unwelcome news just before the new year. Unfortunately, it wasn't about lawsuits, fines and penalties. It was about the competition. As one of its final actions for 2012, the U.S. Food and Drug Administration approved the anti-coagulant drug apixaban – a product that Bristol-Myers Squibb and Pfizer sells under the brand name Eliquis.
This drug has already been approved for use in the E.U. as well as Japan, but in the U.S., the FDA denied approval for Eliquis twice on the grounds that more research was needed. According to a recent study (Apixaban for Reduction In STroke and Other ThromboemboLic Events or ARISTOTLE), Eliquis was more effective than warfarin (Coumadin) in treating patients with atrial fibrillation (AR). Warfarin, actually a common type of rat poison, has the advantage of being inexpensive (always the primary consideration in the U.S. profit-driven healthcare “system”). However, patients who take it require frequent monitoring for possible interactions and to insure they are getting the correct dose.
This was one of the attractive features of Pradaxa. Because there are far fewer interactions to worry about, patients on Pradaxa require less monitoring. The danger is that while hemorrhaging from Coumadin can be stopped by dosing with Vitamin K – which allows the blood's clotting factor to kick in – there is no antidote for hemorrhaging caused by Pradaxa, other than to administer emergency dialysis in order to get the drug out of the patient's system. The reason is that Pradaxa is a “direct Factor Xa inhibitor” (pronounced “Ten-A” ). Factor Xa is the enzyme that allows blood to clot in the first place. Coumadin suppresses the action of Vitamin K, which allows the production of Factor Xa. This is why doses of the vitamin can help stop bleeding in those patients when it occurs.
Eliquis is also a Factor Xa inhibitor – meaning it also acts directly on the clotting enzyme, and may pose some danger of fatal bleeding like Pradaxa. There is a difference, however; while Pradaxa is eliminated from the blood by the kidneys, Eliquis leaves the system by way of the liver. A study published on the American Heart Association website in July of 2012 showed that all three major direct Factor Xa inhibitors – Pradaxa, Xarelto (rivaoxaban) and Eliquis were approximately equal in terms of their effectiveness when it came to preventing strokes and treating AR. However, there was a lower risk of fatal hemorrhaging in patients who were treated with Eliquis. One reason may be due to the fact that elderly patients frequently suffer from reduced kidney function; their livers on the other hand may do a better job of eliminating the drug from the bloodstream.
This is all good news for Bristol-Myers Squibb and Pzifer; stock prices for both companies shot up in the wake of the news. On the other hand, Pradaxa has a two-year head start on Eliquis; the companies' sales reps will have their work cut out for them convincing doctors to switch their patients over to the new medication. A New York Times article suggests that many doctors are taking a “wait-and-see” approach before they consider changing their patients' prescriptions.
There's a great deal at stake; approximately one-fourth of people over the age of forty develop AR at some point. With an aging population and a health care “system” that continues to focus on profits and the bottom line more than the good of patients, the manufacturers of Eliquis stand to make between one and five billion dollars before its all said and done.
N/A. “FDA Clears Anti-Clotting Drug Eliquis.” USA Today, 28 December 2012.
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Rosenbaum, Lisa. “Another Choice for Combatting Clot? Apixaban for Patients with atrial Fibrillation.” Now@NEJM, 14 September 2011. Available at http://blogs.nejm.org/now/index.php/another-choice-for-combatting-clot-apixaban-for-patients-with-atrial-fibrillation/2011/09/14/ .
Schneeweiss, Sebastian MD et. al. “Comparative Efficacy and Safety of New Oral Anticoagulants in Patients With Atrial Fibrillation.” American Heart Association, 10 July 2012. Available at http://circoutcomes.ahajournals.org/content/5/4/480.
Thomas, Katie. “F.D.A. Clears Anticlotting Drug by Bristol and Pfizer.” New York Times, 28 December 2012.
Warner, Jennifer. “FDA Approves New Blood Thinner Eliquis.” WebMD, 31 December 2012. Available at http://www.webmd.com/heart-disease/atrial-fibrillation/news/20121231/fda-blood-thinner-eliquis.
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