BI Receives Priority Review for Pradaxa Antidote
Boehringer Ingelheim should see an FDA decision on its idarucizumab blood-thinning antidote by October, following receipt of priority review last week.
BI touts the drug as the first antidote to dabigatran, the active ingredient in its own Pradaxa, one of a new class of anticlotting drugs that has been found to have significant bleeding risks compared with older anticoagulants including warfarin.
The company is studying the drug specifically in patients needing some kind of emergency intervention following Pradaxa use.
Results from three Phase I trials show the drug reversed Pradaxa’s (dabigatran etexilate mesylate) anticlotting effects without leading to procoagulation, BI said last week. The company BLA for the drug, submitted in February, also includes interim data from an ongoing Phase III trial.
Priority review obligates the FDA to make a decision on whether to approve the drug within six months, instead of the usual 10-month timeline. Idarucizumab also was granted accelerated approval, which is reserved for drugs that significantly improve treatment for serious conditions and whose safety and efficacy can reasonably be assumed from early-stage results. — Lena Freund