None Available To Help Patients Who Undergo Emergency Surgery Or When There Is Life-Threatening Uncontrolled Bleeding
UPDATE: On October 16, 2015 the FDA granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
Eliquis, Savaysa, and Xarelto are touted for their ease of use as regards both patient and physician, but these FXa inhibitor class anticoagulants have one major drawback in common: There is no antidote.
This alarming fact was again front and center when we read this September 25, 2015 Medscape article, "EMA Recommends Approval of Idarucizumab (Praxbind), a Dabigatran-Specific Antidote".
Of course, Praxbind will be useful in cases where patients have to undergo emergency surgery or when life-threatening or uncontrolled bleeding occurs when on Pradaxa (dabigatran).
As suggested by that article's headline, however, Praxbind will only work to stop excessive bleeding associated with Pradaxa, which is a direct thrombin inhibitor. It is not intended for use in patients with acute bleeding while on Eliquis, Savaysa, or Xarelto.
Portola Pharmaceuticals is in the process of developing Andexanet alfa, a reversal agent or antidote for all Factor Xa inhibitors, such as Eliquis, Savaysa, or Xarelto.
When will Praxbind and Andexanet be approved by the FDA and become available to patients in the US?
Here is one perspective, as set forth in a September 28, 2015 Seeking Alpha article, "Portola: Who's Afraid Of Praxbind?":
When will Andexanet alfa be approved
That is the critical question in this equation. Praxbind, I believe, will be in the EU market by January 2016 or earlier, and having received Priority review in April 2015 with the FDA, should also be in the US no later than that.
Andexanet alfa is also in the last stages of its clinical development, and looks to be in the market no later than mid-2016. Just 2 weeks ago, its phase 3 study with Xarelto concluded, meeting all primary and secondary endpoints, just like its earlier phase 3 study with Eliquis had done....
Additional information comes from an August 27, 2015 Portola News Release about the status of Andexanet: "The Company expects to submit a Biologics License Application (BLA) for Andexanet alfa to the FDA under an Accelerated Approval pathway at the end of 2015."
It seems, therefore, that Praxbind will get an estimated 6-month "head start" on Andexanet.
This is good news for patients who are on Pradaxa, less so for those people using Eliquis, Savaysa, or Xarelto.
However, at the present time, there is no available antidote for Pradaxa nor Xarelto, Savaysa, and Eliquis. Therefore, irreversible bleeding events, which can result in deaths, remain a real and serious safety issue for these newer blood-thinning drugs.