BI’s Idarucizumab Instantly Reverses Dabigatran in Phase 3 Study
An interim Phase 3 analysis of idarucizumab shows the drug reverses the anticlotting effect of Pradaxa within minutes in patients requiring urgent procedures or with serious bleeding complications, Boehringer Ingelheim reports.
The study achieved 100 percent maximum reversal of BI’s Pradaxa (dabigatran etexilate) as median value across all 81 patients who had elevated anticoagulation levels, the drugmaker says. Reversal, which was evident immediately after administering the first vial, was complete in all but one patient.
Nearly 90 percent of patients experienced normal coagulation levels after four and 12 hours, according to lab tests. Cessation of bleeding during surgery was reported in 92 percent of patients who required surgery or invasive procedures.
BI considers the interim results extremely encouraging, says Jörg Kreuzer, vice president for cardiovascular medicines. The study is ongoing.
The company submitted idarucizumab via an accelerated approval pathway in the U.S., EU and Canada. It is the only specific reversal agent for a novel oral anticoagulant in regulatory review, BI says.
In April, the FDA granted priority review for idarucizumab, setting it on course for an approval decision by October. — Jonathon Shacat