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Xarelto Receives FDA Priority Review – But, is it Really a Major Advancement?

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When a new drug is introduced and the manufacturer claims that the drug is supposed to either offer a major advancement in treatment or provide a treatment where no adequate treatment exists, the U.S. Food and Drug Administration gives the drug “priority review” status, meaning more FDA resources will be directed towards reviewing the drug than would be typical, with the goal of completing review of the drug in six months rather than the ten to twelve months the FDA usually spends reviewing standard drugs.

Xarelto, like its competitor Pradaxa, has been in a race to grab the potentially lucrative $10 billion market to replace the generic blood thinner, warfarin, which is used in treatment of atrial fibrillation – a rapid, irregular heart rhythm. Boehringer Ingelheim’s blockbuster drug, Pradaxa, got a leg up on the market when it was approved in 2010. Xeralto, licensed by Janssen Pharmaceuticals from Bayer, followed closely by receiving FDA approval in 2011. Eliquis, an effort from Pfizer and BMS, is the third drug in the new-generation blood thinner market, but has fallen behind with word from the FDA that more information would be needed before it could be approved.

Janssen now looks to expand the Xeralto market with additional indications for use in treatment of deep vein thrombosis (DVT) and pulmonary embolism. But is Xarelto really a major advancement in the treatment of DVT?

The treatment of DVT requires an anticoagulant to prevent a blood clot from getting bigger. Two different types of anticoagulants have been used to treat DVT for years – heparin and warfarin. Heparin is generally prescribed first, because it works immediately to prevent further clotting. After the initial heparin treatment, warfarin may also be prescribed to prevent another blood clot from forming.

Manufacturers of new drugs, such as Xarelto and Pradaxa, seek to capture the warfarin market for DVT treatment. Although the manufacturers point to improvements over warfarin, warfarin still has one major advantage that can’t be ignored – the blood thinning action of warfarin can be quickly reversed in patients who suffer bleeds by administering vitamin K. On the other hand, each of the three of the new-generation blood thinners lacks a way to reverse the drug’s intended action, leading some top cardiologists to say that they are not ready to prescribe any of the new thinners.

The lack of a reversal agent is part of the reason lawsuits have been brought against Pradaxa’s manufacturer Boehringer Ingelheim since Pradaxa hit the market in 2010. Many people are worried that Xarelto may be following the same path. According to the Adverse Events Monitor, a report that tracks the FDA’s Adverse Event Reporting System, Xarelto was the subject of 990 primary suspect reports in the first two quarters of 2012, with the top reported adverse event being pulmonary embolism.

Given the extent of adverse events associated with Xarelto, the FDA’s allocation of additional resources to investigate the drug prior to approving it for additional uses is warranted. It seems far from certain that Xarelto is really a major advancement from warfarin, and because it lacks a reversal agent, presents risks similar to those that have resulted in litigation over Boehringer Ingelheim’s Pradaxa.

2 Comments

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  1. Duncan says:
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    Warfarin can be rapidly reversed? Your knowledge is questionable. Please provide this information. Vitamin K isn’t rapid as well as the many other pathways that warfarin affects in the clotting cascade. Why are you not trying to represent the many patients affected by the vast side effects of warfarin?

  2. Mark says:
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    Warfarin cannot be rapidly reversed with vitamin K. If you want to reverse warfarin quickly, you will need to use the same agents that are predicted for factor Xa inhibitors – Prothombrin Complex Concentrate. THAT will likely only be found in ER departments. Furthermore, you should do some research on time out of therapeutic range for warfarin patients. As a point of fact, the VA did a trial of 120,000 patients and which concluded that warfarin patients were actually in range only 58% of the time; a finding that has been echoed by many other studies with similar results. Translated, that means that nearly half the time warfarin patients are either sub-therapuetic or supra-therapuetic which can lead to either stokes/systemic embolisms or, on the other hand, hemorrhages. Lastly, your article implies “class effect” with Pradaxa and Xarelto which is simply not the case. They are both anti-coagulants however, that’s where the similarity ends. They both have very different mechanism of actions and consequently can’t be compared in this manner.

    I would recommend doing more research before making statements regarding things you clearly know little about.