Phase I Data Published in The Lancet Show Boehringer Ingelheim's Idarucizumab* Reverses Anticoagulant Effects of Dabigatran
- Doses of 2g and over led to immediate, complete and sustained reversal of dabigatran-induced anticoagulation in healthy volunteers
Jun 16, 2015, 08:30 ET
RIDGEFIELD, Conn., June 16, 2015 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that The Lancet published results from a phase I study investigating the effects of idarucizumab*, an investigational agent, in reversing the anticoagulant effect of dabigatran** in healthy volunteers. The data demonstrate that complete reversal was achieved following administration of idarucizumab. It was administered as either a single 5 minute infusion or as two five minute infusions given one hour apart. The reversal effect was sustained for more than 24 hours for all doses of 2g and above.
In this phase 1 study, 47 male volunteers aged 18-45 received 220 mg of dabigatran twice daily for three days, followed by a single dose on day four. Idarucizumab was administered approximately two hours after the final dabigatran dose, in doses of 1 g, 2 g, or 4 g as a five-minute infusion, or as two five-minute infusions of 5 g and 2.5 g one hour apart. The primary endpoint was incidence of drug-related adverse events, analyzed in all randomly assigned participants who received at least one dose of dabigatran. In this study, there were no clinically relevant idarucizumab-related adverse events. Results showed that idarucizumab immediately and completely reversed dabigatran-induced anticoagulation and no procoagulant effects were found when measured by a specific assay.
"These phase I results published in The Lancet add to the growing body of evidence supporting idarucizumab. We are committed to the continued study and development of this specifically targeted reversal agent," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "If approved, idarucizumab has the potential to be a significant evolution in care by providing physicians with an option to rapidly reverse the anticoagulant effect of dabigatran in rare emergency situations."
These data were initially presented at the American Heart Association's (AHA) Scientific Sessions 2013. Additional phase I data were presented at the AHA Scientific Sessions 2014 and the 2014 American Society for Hematology annual meeting (ASH).
In April 2015, the U.S. Food and Drug Administration granted priority review to Boehringer Ingelheim's Biologics License Application (BLA) for idarucizumab.
Idarucizumab is a humanized antibody fragment, or Fab, being investigated as a specific reversal agent for the anticoagulant effect of dabigatran in patients needing emergency surgery or urgent procedures or for life threatening or uncontrolled bleeding events. The safety and efficacy of idarucizumab has not been established.
Boehringer Ingelheim scientists discovered and are developing idarucizumab. The research program was initiated in 2009, before dabigatran was launched in the U.S. in 2010. The company has a rich history in supporting the development and manufacturing of biopharmaceutical products, and idarucizumab is an example of this dedication and experience.
The company completed three phase I trials of idarucizumab in human volunteers, and included these data in the idarucizumab Biologics License Application (BLA) submitted to the U.S. Food and Drug Administration (FDA).
Boehringer Ingelheim is continuing to evaluate idarucizumab in RE-VERSE AD™, a phase III global study that includes patients taking dabigatran who have uncontrolled or life-threatening bleeding or require emergency procedures. The study is the first of its kind in patients, and has been underway since May 2014 enrolling patients in more than 35 countries.
Idarucizumab was granted Breakthrough Therapy Designation by the FDA in June 2014.
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For more than 125 years, Boehringer Ingelheim has been focused on improving the lives of patients. In keeping with the company commitment to do the most good for the most people, Boehringer Ingelheim works hard to ensure its medicines are accessible to everyone who needs them, including senior citizens and families on limited incomes. The Boehringer Ingelheim Cares Foundation Patient Assistance Programs (BI-PAP) make Boehringer Ingelheim medicines available free of charge to patients who are without pharmaceutical insurance coverage, and who meet certain household income levels.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates and more than 47,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.
In 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.
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* Idarucizumab is the proposed International Nonproprietary Name (pINN).
** Dabigatran is the active ingredient in Pradaxa® (dabigatran etexilate mesylate)
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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