German giant Boehringer Ingelheim is racing to the market with an antidote to its blockbuster blood-thinner Pradaxa, securing the FDA’s coveted breakthrough therapy designation for its in-development treatment.
The antidote is a fully humanized antibody fragment designed to reverse the anti-coagulant effects of Pradaxa, which prevents clotting by blocking the enzyme thrombin. Dubbed idarucizumab, Boehringer’s reversal agent charted immediate, complete and sustained reversal of Pradaxa’s effects in a Phase I study, the company said, and a Phase III trial is in the midst of enrollment.
The FDA’s breakthrough tag guarantees a speedy review and a front-row seat with regulators, and Boehringer is planning to pursue an accelerated approval for its antidote.
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