Boehringer Ingelheim Release: Updated Phase III Results Reinforce Safety And Efficacy Of Praxbind (idarucizumab) In Urgent Situations

INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim announced updated results from data for 494 patients participating in the ongoing phase III RE-VERSE AD^™ study, which showed that administration of 5g of idarucizumab immediately reversed the anticoagulant effect of dabigatran, the active ingredient in Pradaxa^® (dabigatran etexilate).¹ Idarucizumab, marketed as Praxbind^®, is the first and only approved specific reversal agent for a non vitamin K antagonist oral anticoagulant (NOAC) and RE-VERSE AD^™ is the largest patient study investigating a reversal agent for a NOAC.^2-4 The updated results were presented at the American Heart Association (AHA) Scientific Sessions 2016 in New Orleans, Louisiana.¹

“These insights, together with the confirmed safety profile of dabigatran, can truly give physicians confidence in choosing a NOAC that provides a new level of care for their patients.”

RE-VERSE AD^™ includes the types of patients healthcare professionals may treat in real-world emergency settings.² The study enrolled patients treated with dabigatran who had uncontrolled or life-threatening bleeding (Group A, n=298, 60 percent) or required emergency surgery or an invasive procedure (Group B, n=196, 40 percent).¹ This includes severely ill or injured patients (e.g. patients in an automobile accident with multiple injuries, patients with aortic aneurysm or patients receiving an organ transplant) who as such require urgent reversal of dabigatran.²

The primary endpoint of reversal of the anticoagulant effect of dabigatran within four hours was 100 percent^1,2, as measured by diluted thrombin time (dTT) and ecarin clotting time (ECT) (95% CI, 100-100).^1,2 Of note, reversal was evident immediately after administration of idarucizumab.¹ For Group A patients with extracranial bleeding, median time to confirmation of haemostasis was 3.5 to 4.5 hours, depending on anatomical location.¹ The source of bleeding was similar to the previous interim analysis (45 percent gastrointestinal, 33 percent intracranial haemorrhage).^1,5 In Group B, 93 percent of patients experienced normal haemostasis during surgery, and the median time to the operating room was 1.6 hours after administration of idarucizumab.¹

No safety signals attributed to idarucizumab were detected. All serious adverse events reported were considered to be related to the index event or comorbidities rather than to study treatment. Thrombotic events occurred in 6.3 percent (31/494) of patients within 90 days after idarucizumab administration. Approximately two-thirds of these patients received no anticoagulation prior to the event. Mortality rates were 12.3 percent (Group A) and 12.4 percent (Group B) at 30 days, and 18.7 percent (Group A) and 18.5 percent (Group B) at 90 days. ¹

“The availability of idarucizumab as a reversal agent for dabigatran is an important development in anticoagulation care, and RE-VERSE AD^™ is the most robust examination of its real-world use and impact,” said Dr. Charles Pollack, lead investigator of RE-VERSE AD^™, Professor of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, US. “These results further support that, although idarucizumab is likely to be rarely used in light of the safety profile of dabigatran, a specific reversal agent provides an important therapeutic option for physicians and patients.”

“With these results, we have an unprecedented wealth of data on the use and effects of idarucizumab in urgent situations,” said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “These insights, together with the confirmed safety profile of dabigatran, can truly give physicians confidence in choosing a NOAC that provides a new level of care for their patients.”

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http://www.boehringer-ingelheim.com/press-release/updated-phase-iii-results-reinforce-safety-and-efficacy-of-praxbind