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U.S. health regulators approved Praxbind, a reversal agent made by Germany Private held Boehringer Ingelheim, for use in emergency situations by patients taking the company's widely used Pradaxa blood thinner. Praxbind, an intravenous injection, is the first reversal agent approved specifically for Pradaxa and works by binding to the drug compound to neutralize it.
The FDA in 2010 approved Pradaxa, a pill, to prevent stroke in patients with a common heart rhythm irregularity called atrial fibrillation. Although Pradaxa is highly effective at preventing blood clots that can cause strokes in such patients, until now there has been no way to reverse the drug's effects.
Portola Pharmaceuticals Inc plans before the end of 2015 to seek FDA approval for its agent that has proven highly able to reverse the effects of Johnson & Johnson's Xarelto and Eliquis from Bristol-Myers Squibb and Pfizer Inc. As blood thinners, Pradaxa, Xarelto and Eliquis are all meant to be more convenient alternatives to warfarin, an oral anti-coagulant that has been sold for more than 60 years but which comes with serious bleeding risks, difficult dietary restrictions and the need for routine blood monitoring. Vitamin K is often used to reverse the effects of warfarin, when bleeding emergencies occur.
Xarelto and Eliquis, approved in 2011 and 2012, respectively, each have annual sales of about $1.6 billion and thin the blood by blocking Factor Xa, a protein highly involved in the blood-clotting process. Pradaxa, which had 2014 sales of $1.3 billion, works by directly blocking a clotting protein called thrombin.
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