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Re: genisi post# 169754

Monday, 11/18/2013 2:00:16 PM

Monday, November 18, 2013 2:00:16 PM

Post# of 257580
B-I presents phase-1 data on Pradaxa antidote at AHA:

http://in.reuters.com/article/2013/11/18/us-pradaxa-antidote-idINBRE9AH0O820131118

…researchers on Monday said data from a Phase 1 study of Pradaxa involving almost 150 healthy volunteers suggest a safe and effective antidote to Pradaxa may be within reach in coming years. The antidote is a fragment of a monoclonal antibody…

…Volunteers received the antidote through 5-minute intravenous infusions after taking Pradaxa for four days. "At the end of the infusion we observed an immediate and complete reversal" of Pradaxa in terms of the drug's anti-coagulation effect, Boehringer's Glund said…. Moreover, he said no serious side effects were seen with the antidote. "It has a very positive safety profile."

Pradaxa cannot be reversed by PTLA’s PRT4445 because (unlike Xarelto, Eliquis, Edoxaban, and Betrixaban) Pradaxa is not a Factor Xa inhibitor.

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