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Título: Boehringer Ingelheim’s Investigational Antidote for Pradaxa® (dabigatran etexilate mesylate) Receives FDA Breakthrough Therapy Designation
Fecha: 26-06-2013
Ridgefield,CT, June 26, 2014 –Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Foodand Drug Administration (FDA) has granted Breakthrough Therapy Designation toidarucizumab*, an investigational fully humanized antibody fragment, or Fab,being studied as a specific antidote for Pradaxa (dabigatran etexilatemesylate).
“Boehringer Ingelheim is pleased thatthe FDA has granted Breakthrough Therapy Designation for idarucizumab to helpexpedite 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 patientstaking PRADAXA. We continue to investigate the potential of idarucizumab as atherapeutic option should a patient experience uncontrolled bleeding or need toundergo emergency surgery or another invasive procedure.”
The FDA established the Breakthrough Therapy Designation as ameans to help accelerate the development and review of drugs for serious orlife-threatening conditions if preliminary clinical evidence indicates the therapymay demonstrate a substantial improvement over existing therapies on one ormore clinically significant endpoints.
Boehringer Ingelheim is planning to pursue an AcceleratedApproval pathway for idarucizumab.
Data from a phase I study presentedat the American Heart Association Scientific Sessions in 2013 showed thatidarucizumab was able to achieve immediate, complete and sustained reversal ofdabigatran-induced anticoagulation in healthy humans.
A global phase III study, RE-VERSE AD™, is underway in patientstaking PRADAXA who have uncontrolled bleeding or require emergency surgery orprocedures (NCT02104947). Currently, no U.S. sites havebeen 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 morethan 27,000 patients and were conducted without the use of an antidote,” saidLuik. “As a company whose core mission is always to improve patient care, weare evaluating whether idarucizumab could be an additional therapeutic optionin certain emergency situations.”
Currently, no specific antidotes for newer oral anticoagulants(NOACs) are available. Idarucizumab is still under investigation and has notbeen approved for clinical use.
Fuente: endovascular.es

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