Aug 252015

New oral anticoagulants like dabigatran, apixaban and rivaroxaban have advantages over warfarin: not requiring regular monitoring for efficacy; faster onset of action; shorter half-lives. Unlike warfarin, they've had the significant disadvantage of having no proven antidote for the bleeding that inevitably occurs when any anticoagulant is given to thousands of people. [lawsuits]

Boehringer Ingelheim, makers of the direct thrombin inhibitor dabigatran, announced a solution in a new trial in the New England Journal of Medicine: idarucizumab, a monoclonal antibody that binds dabigatran with 350x the affinity of thrombin.

In early results of the ongoing safety and efficacy trial, investigators gave 5 g of idarucizumab to 51 patients (mostly elderly and with atrial fibrillation) experiencing bleeding while taking dabigatran, and 39 undergoing urgent surgery or procedures while taking the drug.

Idarucizumab reversed dabigatran's effects in almost all patients with abnormal coagulation tests. Five patients had clots (stroke, DVT, PE, or MI) in the month following cessation of dabigatran and receipt of idarucizumab -- all patients were off anticoagulation when they had their clots.

33 of the 36 patients (92%) taking dabigatran who underwent invasive procedures or surgeries after receiving idarucizumab were considered to have normal hemostasis by their surgeons; 2 were described as having mildly abnormal hemostasis and one moderately abnormal hemostasis.

The company is seeking fast-track FDA approval for idarucizumab, whose cost is yet to be announced. A unit of fresh frozen plasma costs ~$350, with full reversal of warfarin costing ~$1,500-3,000 in most patients.

Read more: Idarucizumab for Dabigatran Reversal. (NEJM)

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Dabigatran-induced bleeding: antidote (idarucizumab) on the way