Boehringer Ingelheim announced 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.