Dabigatran Antidote Gets FDA Okay for Faster Review

Shelley Wood

June 26, 2014

INGELHEIM, GERMANY - The US Food and Drug Administration (FDA) has granted "breakthrough-therapy designation" to idarucizumab, an investigational fully humanized antibody fragment (FAB) intended to be used as an antidote for dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim)[1]. The manufacturer announced the news of the agency's decision earlier today, noting that the designation is expected to "expedite its development."

Results from a phase 1/2 study of idarucizumab, released at last year's American Heart Association Scientific Sessions, showed that the agent can produce immediate, complete, and sustained reversal of dabigatran-induced anticoagulation in healthy human volunteers, with no off-target toxicity. A phase 3 study, RE-VERSE AD , is already under way in people taking dabigatran who develop uncontrolled bleeding or who require emergency surgery or other procedures, the company notes. European sites are actively enrolling in the trial, although no US sites have started enrollment.

According to a company press release, "breakthrough-therapy designation is a means to help accelerate the development and review of drugs for serious or life-threatening conditions if preliminary clinical evidence indicates the therapy may demonstrate a substantial improvement over existing therapies on one or more clinically significant end points."

Unlike bleeds related to warfarin, which can be reversed using low-dose vitamin K1, there are no currently approved agents for reversing bleeds, or reversing the anticoagulant effects in the case of emergency surgery, with the newer oral anticoagulants. Boehringer Ingelheim recently reached a settlement with approximately 4000 individuals involved in state and federal lawsuits who claimed dabigatran caused serious adverse events, the vast majority of which were bleeding-related events, including fatal bleeding.

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