Boehringer Ingelheim files BLA with FDA for Pradaxa antidote idarucizumab

German family-owned pharma major Boehringer Ingelheim has submitted a Biologics License Application (BLA) to the US Food and Drug Administration, requesting an Accelerated Approval pathway, for the use of idarucizumab to reverse the anticoagulant effect of dabigatran, the active ingredient in Pradaxa (dabigatran etexilate mesylate).

The new application includes Phase I data in volunteers showing that idarucizumab provided immediate, complete and sustained reversal of the anticoagulant effect of dabigatran. Boehringer has yet to report financials for 2014, but sales of Pradaxa increased by nearly 9% in euro terms in 2013 to hit 1.2 billion euros ($1.35 billion at current exchange rates).

Follows just eight months after Breakthrough designation