Boehringer Ingelheim

FDA OKs first reversal agent for Pradaxa

Monday, October 19, 2015

The FDA has 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.

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EMA fast-tracks antidote to Pradaxa

Monday, September 28, 2015

The EMA has recommended granting a marketing authorization, following Accelerated Assessment, for Praxbind (idarucizumab) as a specific antidote to the anticoagulant medicine Pradaxa (dabigatran etexilate), when rapid reversal of its effect is required. Praxbind is to be used when a patient taking Pradaxa needs to undergo an emergency surgery or when life-threatening or uncontrolled bleeding occurs.

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