Idarucizumab (Praxbind®) is a fully humanized monoclonal antibody fragment, or Fab, with high binding affinity for the oral direct thrombin inhibitor dabigatran (Pradaxa®) that selectively and immediately neutralizes its anticoagulant activity. Idarucizumab is approved for the treatment of patients treated with dabigatran when reversal of its anticoagulant effects is needed in emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding.
Dabigatran is the only one of the four direct oral anticoagulants approved by the Food and Drug Administration that targets thrombin. Direct oral anticoagulants offer key advantages over warfarin, including improved prevention and treatment of thrombosis and fewer bleeding events. However, the absence of specific antibodies to reverse anticoagulation with these agents has been a critical disadvantage.
A single dose of idarucizumab is able to rapidly and completely reverse the anticoagulant effect of dibigatran, with an acceptable safety profile.
About the Connexion Healthcare Oncology Center of Excellence
Connexion Healthcare is a full-service global provider of strategic medical and scientific communications with decades of experience providing exceptional service to the pharmaceutical industry. We provide services through 2 Centers of Excellence—Oncology and Rare Disease—and possess core expertise in these therapeutic areas and their marketplaces.
Connexion Healthcare’s Oncology Center of Excellence offers executive talent with decades of experience in the pharmaceutical industry. Our medical directors have conducted oncology research at leading institutions and major pharmaceutical companies. Our account leads have years of project execution expertise, and our medical editors are versed in the language of oncology. Our design leads are tops in their fields and ensure that your objectives are met effectively and even surpassed in an industry-eloquent and compliant manner. Our team works with you to conceive a strategy and execute communications through your product’s lifespan – from drug discovery through market launch and beyond. With particular expertise in phase 2 through postlaunch, we will engage with you wherever you are in development and whenever you need us.
For further information regarding the Oncology Center of Excellence at Connexion Healthcare and how we can develop oncology communications to differentiate therapies by their unique attributes, contact:
Larry Lunak, Senior Vice President
Valery Sudakin, PhD
Hematology/Oncology Scientific Services