BI files its Pradaxa 'antidote' in North America, EU
- Boehringher Ingelheim has submitted applications to the FDA, the EMA and Health Canada for idarucizumab, which is designed to reverse the effects of its anticoagulant Pradaxa (dabigatran).
- This is the first submission of an agent designed to reverse the anticoagulant effects of (CORRECTED) dabigatran, the active ingredient in Pradaxa.
- Submissions are based results of a phase I study in which subjects experienced an immediate, complete and sustained reversal of the effect of Pradaxa.
Idurucizumab is an investigational fully humanized antibody fragment (Fab), which is being evaluated as a specific antidote for Pradaxa (dabigatran)—also marketed by Boehringer Ingelheim (BI). Submission of this drug represents a breakthrough for BI, which has dealt with reports of numerous Pradaxa-related deaths (roughly 280) and adverse events (roughly 1,400) in the last five years. Although not all of the adverse events were related to internal bleeding, many were. In addition, BI settled a $650 million class action lawsuit last year as well.
When Biopharma Dive covered this topic last year, our takeaway was: Having an antidote available to moderate the effects of Pradaxa-induced anticoagulation will undoubtedly improve this novel anticoagulant’s therapeutic value, as well as its sales potential. BI is now initiating phase III trials and is a step closer to a fully approved Pradaxa antidote.