Full Approval Granted to Reversal Agent for Idarucizumab

This morning, the U.S. Food and Drug Administration (FDA) provided full approval to Boehringer Ingelheim for idarucizumab (Praxbind), its specific reversal agent for dabigatran etexilate mesylate (Pradaxa).

The decision converts the drug’s accelerated approval, granted in October 2015, to full approval, making it the first and only specific reversal agent for a novel oral anticoagulant (NOAC) to be fully approved by the FDA.

Davigatran etexilate mesylate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Idrucizumab is indicated for patients treated with dabigatran etexilate mesylate when reversal of the anticoagulant effects of dabigatran is necessary for emergency surgery, urgent procedures, or in circumstances that contain life-threatening or uncontrolled bleeding.

In October 2015, accelerated approval was granted to idarucizumab by the FDA with continued approval contingent based upon results from the largest study to investigate a reversal agent for a NOAC, the Phase 3 RE-VERSE Ad trial, which was initiated in May 2014.

The trial enrolled a total of 503 patients at 173 sites in 39 countries, and results showed that idarucizumab immediately reversed the anticoagulant effect of dabigatran etexilate mesylate.

"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 of Clinical Development and Medical Affairs at Boehringer Ingelheim Pharmaceuticals, Inc. in a press release. "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."¹

The primary endpoint in the RE-VERSE study, the degree of reversal of the anticoagulant effect of dabigatran achieved by idarucizumab within 4 hours, was measured by diluted thrombin time (dTT) and ecarin clotting time (ECT). The endpoint was met, as most patients had complete reversal of anticoagulation by ECT (82%) and dTT (99%). Additionally, no adverse safety signals were observed, and there was a low rate of thrombotic events.

Per Boehringer Ingelheim, healthcare providers should consider resuming anticoagulant therapy as soon as medically appropriate due to the risk of thrombosis associated with patients' underlying conditions. Idarucizumab is stocked in more than 3,000 hospitals in all 50 states nationwide. Healthcare providers and patients can conveniently search for institutions in the US where idarucizumab is stocked by using the zip code locator tool available at Praxbind.com.

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Reference:

1. FDA Provides Full Approval to Praxbind, Specific Reversal Agent for Pradaxa. Boehringer Ingelheim. https://www.prnewswire.com/news-releases/fda-provides-full-approval-to-praxbind-specific-reversal-agent-for-pradaxa-300631175.html. Accessed April 17, 2018.