Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to idarucizumab, an investigational fully humanized antibody fragment, or Fab, being studied as a specific antidote for Pradaxa (dabigatran etexilate mesylate).
"Boehringer Ingelheim is pleased that the FDA has granted Breakthrough Therapy Designation for idarucizumab to help expedite its development," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We are 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." The FDA established the Breakthrough Therapy Designation as 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 endpoints.
Boehringer Ingelheim is planning to pursue an Accelerated Approval pathway for idarucizumab.
Data from a phase I study presented at the American Heart Association Scientific Sessions in 2013 showed that idarucizumab was able to achieve immediate, complete and sustained reversal of dabigatran-induced anticoagulation in healthy humans.
A global phase III study, RE-VERSE ADT, is underway in patients taking PRADAXA who have uncontrolled bleeding or require emergency surgery or procedures (NCT02104947). Currently, no U.S. sites have been initiated; however, European sites are actively enrolling.
"We are confident in PRADAXA's benefits and safety profile, which were established in five pivotal trials that collectively include more than 27,000 patients and were conducted without the use of an antidote," said Luik. "As a company whose core mission is always to improve patient care, we are evaluating whether idarucizumab could be an additional therapeutic option in certain emergency situations." Currently, no specific antidotes for newer oral anticoagulants (NOACs) are available. Idarucizumab is still under investigation and has not been approved for clinical use.