Praxbind
Generic name: idarucizumab
Treatment for: Reversal Agent for Pradaxa
Boehringer Ingelheim Submits BLA to FDA for Idarucizumab, Investigational Specific Reversal Agent for Pradaxa
Ridgefield, CT, March 2, 2015 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced it has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA), requesting an Accelerated Approval pathway, for the use of idarucizumab to reverse the anticoagulant effect of dabigatran, the active ingredient in Pradaxa® (dabigatran etexilate mesylate).
The new application includes phase I data in volunteers showing that idarucizumab provided immediate, complete and sustained reversal of the anticoagulant effect of dabigatran.
“The submission of this BLA just eight months after receiving Breakthrough Therapy Designation from the FDA provides further evidence of our commitment to delivering on patient and healthcare provider needs,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “We are once again leading the evolution and innovation of anticoagulation care, and the potential approval would enable us to provide physicians with a specifically targeted reversal agent for Pradaxa patients in rare emergency situations.”
Boehringer Ingelheim is continuing to evaluate idarucizumab in RE-VERSE AD™, a phase III global study investigating idarucizumab in actual clinical settings. This is the only trial to examine patients being treated with Pradaxa who are in need of emergency intervention or experience an uncontrolled or life-threatening bleeding event.
“Boehringer Ingelheim has a rich history in contract manufacturing and supporting the development of biopharmaceutical products. The discovery and development of idarucizumab by our own scientists demonstrates our dedication to bringing forth innovative products to fulfill unmet medical needs and improve patient care,” said Luik. “If idarucizumab is approved, Pradaxa would be the first and only novel oral anticoagulant with a specifically targeted reversal agent.”
About Idarucizumab
Idarucizumab is a humanized antibody fragment, or Fab, being investigated as a specific reversal agent for the anticoagulant effect of dabigatran. Pre-clinical studies indicate idarucizumab binds specifically to and inhibits dabigatran.
Phase I data in healthy volunteers demonstrated the potential of idarucizumab to achieve immediate, complete and sustained reversal of dabigatran-induced anticoagulation. In these placebo-controlled studies, idarucizumab did not cause any clinically relevant side effects. No pro-thrombotic effect was observed after the administration of idarucizumab and no return of anticoagulant activity of dabigatran was seen over time at adequate doses. Other phase I data in healthy volunteers show that idarucizumab restores wound-site formation of fibrin, the main component of a blood clot.
In June, the FDA granted Breakthrough Therapy Designation to idarucizumab.
About the Boehringer Ingelheim Cares Foundation Patient Assistance Programs
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.
For more information please visit www.us.boehringer-ingelheim.com/
Source: Boehringer Ingelheim Pharmaceuticals, Inc.
Posted: March 2015
Related articles
- FDA Provides Full Approval to Praxbind (idarucizumab), Specific Reversal Agent for Pradaxa - April 17, 2018
- FDA Approves Praxbind (idarucizumab) as a Reversal Agent for the Anticoagulant Pradaxa - October 16, 2015
- FDA Grants Priority Review to Boehringer Ingelheim’s Biologics License Application for Idarucizumab - April 23, 2015
Praxbind (idarucizumab) FDA Approval History
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