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Breakthrough Therapy Status for Pradaxa Antidote

Idarucizumab being evaluated to specifically reverse the anticoagulant effect of Pradaxa

Boehringer Ingelheim Pharmaceuticals has received an FDA breakthrough therapy designation to help speed the development of an antidote to one of its own drugs. Idarucizumab, an investigational fully humanized antibody fragment (Fab), is being studied as a specific antidote for Pradaxa (dabigatran etexilate mesylate).

The company is investigating the potential of idarucizumab as a therapeutic option should a patient experience uncontrolled bleeding or need to undergo emergency surgery or another invasive procedure.

Data from a phase I study presented at the American Heart Association Scientific Sessions in 2013 showed that idarucizumab was able to achieve immediate, complete, and sustained reversal of dabigatran-induced anticoagulation in healthy humans. A global phase III study, RE-VERSE AD, is under way in patients taking Pradaxa who have uncontrolled bleeding or require emergency surgery or procedures. While no U.S. sites have been initiated, European sites are actively enrolling.

Preclinical studies indicate idarucizumab binds specifically to and inhibits dabigatran with no other expected interactions.

The firm says it remains confident in Pradaxa's benefits and safety profile, which were established in five pivotal trials that collectively include more than 27,000 patients and were conducted without the use of an antidote. Currently, no specific antidotes for newer oral anticoagulants are available. Idarucizumab is still under investigation and has not been approved for clinical use.

Pradaxa is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days; and to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated. It increases the risk of bleeding and can cause significant and sometimes fatal bleeding.

Source: Boehringer Ingelheim Pharmaceuticals; June 26, 2014.

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