FDA breakthrough therapy status helps in accelerating the development and review of drugs for serious or life-threatening conditions if preliminary clinical evidence indicates the therapy may show a substantial improvement over existing therapies on one or more clinically significant endpoints.
Boehringer Ingelheim Pharmaceuticals Medicine & Regulatory Affairs senior vice-president Sabine Luik said the company is 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," Luik said.
The company intends to pursue an accelerated approval pathway for idarucizumab.
Data from the company’s Phase I trial showed that idarucizumab was able to achieve immediate, complete and sustained reversal of dabigatran-induced anticoagulation in healthy humans.
At present, the Phase III RE-VERSE AD trial is underway in patients taking Pradaxa who have uncontrolled bleeding or require emergency surgery or procedures. European sites are actively enrolling while currently no US sites have been initiated .
Pradaxa capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation as well as to treat deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for five to ten days.
They are also indicated to minimize the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.