Boehringer Ingelheim Pharmaceuticals, Inc.today announced that the U.S. Food and Drug Administration (FDA) has provided full approval for Praxbind® (idarucizumab), the specific reversal agent for Pradaxa® (dabigatran etexilate mesylate). Praxbind is indicated for patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
"In the rare event of an emergency situation requiring reversal, treatment decisions must be made quickly and confidently," said Thomas Seck, M.D., vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We believe that the wide availability of Praxbind--and the robust data on its use--can provide patients and healthcare providers with greater assurance in their anticoagulation treatment decisions."
The FDA granted accelerated approval to Praxbind in October 2015, with continued approval contingent upon results from the phase III RE-VERSE AD™ trial, the largest study to investigate a reversal agent for a NOAC. The final results of RE-VERSE AD were published in the New England Journal of Medicine in July 2017, and showed that Praxbind immediately reversed the anticoagulant effect of Pradaxa. The majority of patients had complete reversal of anticoagulation within four hours as measured by ecarin clotting time (ECT 82%) or diluted thrombin time (dTT 99%).
In the RE-VERSE AD study, no adverse safety signals were observed and there was a low rate of thrombotic events. In clinical studies, Praxbind has not shown a procoagulant effect. Healthcare providers should consider resuming anticoagulant therapy as soon as medically appropriate due to the risk of thrombosis associated with patients' underlying conditions.
Praxbind is stocked in more than 3,000 hospitals in all 50 states nationwide. Healthcare providers and patients can quickly search for institutions in the U.S. where Praxbind is stocked by using a zip code locator tool available at Praxbind.com.
Praxbind is distributed by U.S. hospital pharmacy distributors ASD, Cardinal Health, MPB, HD Smith and Morris Dickson. Orders can generally be filled or restocked within 24 hours. Additional information about stocking Praxbind, as well as the zip code locator tool, is available at Praxbind.com or by calling 1?800?542?6257 (Opt 1).
About RE-VERSE AD™
RE-VERSE AD (NCT02104947) is a phase III global study of patients taking dabigatran who require urgent procedures or have uncontrolled bleeding. The final analysis from RE-VERSE AD included data from patients requiring urgent procedures/emergency surgery, e.g. surgery for an open fracture after a fall, or patients with either uncontrolled or life-threatening bleeding complications, e.g. intracranial hemorrhage or severe trauma after a car accident. The primary endpoint, the degree of reversal of the anticoagulant effect of dabigatran (Pradaxa) achieved by idarucizumab within four hours, was measured by dTT and ECT.
The study, which began in May 2014, is the largest study to investigate a reversal agent for a novel oral anticoagulant (NOAC) in real-world emergency settings. It enrolled a total of 503 patients at 173 sites in 39 countries, which were included in one of two groups:
Group A: 301 patients (60 percent) presenting with uncontrolled or life-threatening bleeding (e.g. gastrointestinal [GI] and intracranial [ICH] bleeds)
Group B: 202 patients (40 percent) requiring an invasive procedure or an emergency surgery or intervention (e.g. because of a hip fracture)
About Praxbind® (idarucizumab)
INDICATIONS AND USAGE
Praxbind® (idarucizumab) is indicated in patients treated with Pradaxa® when reversal of the anticoagulant effects of dabigatran is needed:
For emergency surgery/urgent procedures
In life?threatening or uncontrolled bleeding
IMPORTANT SAFETY INFORMATION ABOUT PRAXBIND
WARNINGS AND PRECAUTIONS
Thromboembolic Risk
Dabigatran-treated patients have underlying diseases predisposing them to thromboembolic events. Reversing dabigatran therapy exposes patients to thrombotic risk. Consider resumption of anticoagulant therapy as soon as medically appropriate.
Re-elevatio...
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