Boehringer's Pradaxa reversal drug gets breakthrough therapy status
- 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).
- This designation is based on positive phase I data.
- A phase III trial is underway to evaluate the effects of idurucizumab on patients taking Pradaxa who have uncontrolled bleeding or need emergency surgery.
Phase I results in healthy volunteers showed that idurucizumab was able to achieve immediate, complete and sustained reversal of Pradaxa-induced anticoagulation. The most effective dose was 4 grams. Lower doses resulted in initial reversal that was not sustained in all of the volunteers, or that worked at first and was not sustained.
Biopharma Dive recently reported on the results of legal action taken on behalf of Pradaxa-treated patients who experienced serious side effects related to uncontrolled bleeding after treatment. Lawyer/activist Levin Papantonio recently reached a $650 million settlement on the patients’ behalf. Pradaxa, which competes with Bayer’s Xarelto (rivoroxaban), fills an important therapeutic need in the anticoagulation space. 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.