The data were submitted to the FDA following idarucizumab’s accelerated approval last year, which is granted to therapies that address an unmet medical need.
Interim data from a phase 3 study confirm that a single 5 g dose of idarucizumab, marketed as Praxbind, immediately reversed the anticoagulant effect of dabigatran, which is the active ingredient in the medication Pradaxa.1
Results were presented Saturday at the 65th Scientific Sessions of the American College of Cardiology, which is meeting in Chicago, Illinois.
The study, RE-VERSE AD, involves 123 patients, and supports earlier findings. The results confirm idarucizumab’s value for patients who are taking dabigatran should they need emergency treatment, according to Charles V. Pollack, MD, FACEP, the study’s lead investigator and professor of emergency medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia.
“We have enrolled patients in more than 35 countries, and we look forward to the additional analyses and final results to further support the safety, effectiveness, and impact of idarucizumab,” Pollack said.
Idarucizumab received FDA approval on October 16, 2015, through the agency’s accelerated process, which is granted to therapies that address an unmet medical need. This process requires idarucizumab’s manufacturer, Boehringer Ingelheim, to submit results of ongoing trials to regulators confirming the results. FDA’s announcement specifically mentioned the ongoing study of 123 patients.2
The RE-VERSE AD study addresses the real-world situations that healthcare professionals face: (1) patients with uncontrolled bleeding, or (2) patients who need emergency surgery or an invasive procedure. They study included 66 patients in the first group and 57 patients in the second group.
A 5 g dose of idarucizumab was given to each patient, and reversal was seen in all patients who could be assessed (100 total). The final group included 48 with uncontrolled bleeding and 52 having emergency surgery or invasive procedures. The drug is given through IV injection.
Among those with uncontrolled bleeding the mean time for bleeding to stop after taking the drug was 9.8 hours. In the second group, the mean time to surgery was 1.7 hours after taking the medication. Blood clotting was normal for 92% of these patients. Thrombotic events—the type of events for which they would be taking dabigatran in the first place—occurred in 5 patients between 2 and 24 days after they took idarucizumab.
Twenty-six patients died, but cases appeared related to the original cause for emergency surgery or other comorbidities.
The relationship between idarucizumab and dabigatran is unique. As explained in a presentation in November at the American Heart Association annual meeting, the idarucizumab molecule binds to dabigatran but has been shown to not affect other anticoagulants, which is an important fact for emergency physicians to know.
1. Pollack CV, Reilly P, Eikelboom J, et al. Idarucizumab for reversal of the anticoagulant effects of dabigatran in patients in an emergency setting of major bleeding, urgent surgery, or interventions. Presented at the 65th Scientific Session of the American College of Cardiology, Chicago, Illinois. April 2, 2016. Abstract no. 1130M-05.
2. FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa [press release]. Silver Spring, MD: FDA Newsroom; October 16, 2015; http://www/fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm.