Patient Education Blog

Antidote for Pradaxa (Dabigatran): FDA Approval By End of 2015?

Stephan Moll, MD writes:  A drug in development (Idarucizumab) that reverses the blood thinner Pradaxa® (Dabigatran) is on a very promising path to get FDA approval in the next few months and be available for clinical use by the end of 2015.
Today’s New England Journal of Medicine (NEJM) publication presents the data from the first 90 patients treated in the Pradaxa® reversal trial (called RE-VERSE AD). Enrolled into the study were patients on Pradaxa® who either had major bleeding or needed urgent surgery [reference 1].  All patients received the antidote as 2 injections into the vein over 15 minutes.  The effect of the antidote over the next 24 hours was assessed through laboratory clotting tests (the “primary endpoint”), but also through a clinical assessment how quickly the bleeding stopped or whether there was more than expected bleeding during the surgery (“secondary endpoint”).

The results showed that the antidote was able to completely reverse the blood thinning effect of Pradaxa® and that there was not more than expected bleeding in the patients who underwent urgent surgery after the antidote had been given.  Conclusion is that “Idarucizumab completely reversed the anticoagulant effect of Pradaxa® within minutes”.  The drug was well tolerated.

Relevance:  The FDA has given the antidote Idarucizumab “accelerated approval status” and “priority review” [reference 2].  This means that based on the positive results from the present study, the drug has a good chance to get FDA approval before the end of 2015 and be available for routine clinical use by the end of the year.

Reversal of Other Blood Thinners

A reversal agent (Andexanet) is in development. The key clinical patient trial testing this drug in patients for reversal of the oral blood thinners Xarelto (Rivaroxaban), Eliquis (Apixaban), and Savaysa (Edoxaban) has just started.  Andexanet may have enough data from this study to get FDA approval by the middle of 2016 or earlier, if the clinical trial data look good.

References

  1. Pollack CV et al. Idarucizumab for dabigatran reversal; N Engl J Med 2015;published June 22, 2015.
  2. Boehringer-Ingeheim press release: “FDA Grants Priority Review to Boehringer Ingelheim’s Biologics License Application for Idarucizumab”.  April 23, 2015 (link here).

Disclosures: None

Last Updated: June 22, 2015

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