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FDA grants breakthrough therapy designation to Boehringer’s idarucizumab

26 Jun 2014 (Last Updated June 26th, 2014 18:30)

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Boehringer Ingelheim Pharmaceuticals' idarucizumab, an investigational fully humanised antibody fragment being studied as a specific antidote for Pradaxa.

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The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Boehringer Ingelheim Pharmaceuticals’ idarucizumab, an investigational fully humanised antibody fragment being studied as a specific antidote for Pradaxa.

Boehringer Ingelheim Pharmaceuticals Medicine & Regulatory Affairs senior vice-president Sabine Luik said: "We are committed to innovative research and to advancing care in patients taking Pradaxa.

"We continue to investigate the potential of idarucizumab as a therapeutic option should a patient experience uncontrolled bleeding or need to undergo emergency surgery or another invasive procedure."

The company is planning to pursue an accelerated approval pathway for idarucizumab.

"We continue to investigate the potential of idarucizumab as a therapeutic option should a patient experience uncontrolled bleeding or need to undergo emergency surgery."

In 2013, the company presented data from a phase I study, which showed that idarucizumab was able to achieve immediate, complete and sustained reversal of dabigatran-induced anticoagulation in healthy humans.

Currently, the Phase III RE-VERSE AD study is underway in patients taking Pradaxa (dabigatran etexilate mesylate) who have uncontrolled bleeding or require emergency surgery or procedures. European sites are actively enrolling and no US sites have been initiated currently.

Pre-clinical studies indicated that idarucizumab binds specifically to and inhibits dabigatran with no other expected interactions.

Pradaxa capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and to treat deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for five to ten days.

The capsules are also indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.


Image: Ball-and-stick model of dabigatran etexilate molecule. Photo: courtesy of MarinaVladivostok.