Boehringer’s Pradaxa antidote gets EU approval



Boehringer Ingelheim’s Praxbind, which reverses the effects of its anticoagulant Pradaxa, has been approved in Europe, giving the company a potential boost in this increasingly competitive market.

Pradaxa (dabigatran) is part of a new class of anticoagulants called NOACs (non-vitamin K antagonist oral anticoagulants) that have been challenging the decades-long dominance of warfarin due to their effectiveness and convenience. Other drugs in the class are the Factor Xa inhibitors Xarelto (rivaroxaban) from Bayer, Eliquis (apixaban) from Bristol-Myers Squibb and Lixiana (edoxaban) from Daiichi Sankyo.

The main disadvantage of NOACs, however, is the difficulty of reversing serious bleeding in emergency situations. In May 2014 Boehringer paid out $650 million in the US to settle lawsuits related to these bleeding risks, but the company, regulators and scientists have consistently backed the drug’s positive benefit-risk profile and Boehringer is clear that Praxbind (idarucizumab) would only need to be used in rare emergency situations.

Speaking at the drug’s launch event last week, Professor Charles Pollack, lead investigator of the drug’s RE-VERSE AD study in the US, said: “The uptake of NOACs has not been as brisk as many of us anticipated, especially because there had been so much complaining about warfarin for decades by patients and providers. When we query our colleagues about why they have been slow to switch to a NOAC approach, one of the first things that comes up is that they’re not sure what to do with patients if they bleed. So I think this could certainly remove a barrier to their uptake.”

As Praxbind only works to reverse the effects of Pradaxa, it could give Boerhinger’s drug an edge in the crowded NOAC market, as there is currently no approved antidotes to the Factor Xa inhibitors. US firm Portola Pharmaceuticals is working on one named andexanet alfa, but it is still some way from approval.

The European Commission’s approval is based on data from an interim analysis of the RE-VERSE AD study, where the drug showed complete and sustained reversal for at least 12 hours in almost all patients.

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