Boehringer Ingelheim Pharmaceuticals Inc. announced positive results of its final Phase III trial RE-VERSE AD on Praxbind (idarucizumab) on Tuesday.
The study findings were presented at the International Society on Thrombosis and Haemostasis (ISTH) 26th Biennial Congress. They were also published in the New England Journal of Medicine.
“Emergencies or accidents can happen to anyone," lead investigator of RE-VERSE AD Dr. Charles Pollack said. "Patients with atrial fibrillation on an anticoagulant may feel anxious about how they might be managed in an emergency. RE-VERSE AD has shown that idarucizumab reverses the anticoagulant effect of dabigatran within minutes, so that treating physicians can fully focus on dealing with the emergency at hand.”
The study found that Praxbind reversed the effects of the anticoagulant drug Pradaxa within four hours. This effect was seen in all of the 503 patients in the study. Of the patients, 301 were suffering from uncontrolled or life-threateing bleeding and 202 were facing emergency surgery or other intervention.
The U.S. Food and Drug Administration approved Praxbind under accelerated conditions. FDA approval is contingent on results of the ongoing RE-VECTO study of Praxbind, which should be completed by the end of 2018.
“These final data from RE-VERSE AD are consistent with the results we have seen to-date, which demonstrate the important role idarucizumab can play for patients,” Boehringer Ingelheim, senior vice president of Medicine and Regulatory Affairs Dr. Sabine Luik, said. “The good news for patients and physicians is that idarucizumab is available right now in more than 2,900 hospital pharmacies nationwide, where it can be used to treat patients when urgently needed.”
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