The FDA has granted Breakthrough Therapy Designation to Boehringer Ingelheim’s idarucizumab, a fully humanized antibody fragment being studied as an antidote for Pradaxa (dabigatran), the company said on Wednesday.
The drug is being evaluated to specifically reverse Pradaxa’s anticoagualting properties, the company said.
The company said a 2013 Phase I study showed that idarucizumab was able to achieve instant, complete and sustained reversal of dabigatran-induced anticoagulation in healthy humans. A global phase III study is also underway, testing the drug in patients taking Pradaxa who have uncontrolled bleeding or require emergency surgery or procedures, the German-based company added.
BI is planning to pursue an Accelerated Approval pathway for idarucizumab — which is still under investigation and not approved for clinical use — as no antidotes for newer oral anticoagulants are currently available, the company said.
The FDA established the Breakthrough Therapy Designation to help accelerate the development and review of drugs for serious or life-threatening conditions, as long as preliminary clinical evidence shows the therapy may reveal a substantial improvement over existing therapies on one or more significant endpoints. — Kellen Owings
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