title: Idarucizumab: First Global Approval.
abstract: Idarucizumab (Praxbind(®)) is a fully humanized, monoclonal antibody fragment developed by Boehringer Ingelheim as a specific antidote to reverse the anticoagulant effect of the direct oral thrombin inhibitor dabigatran etexilate (Pradaxa(®)). Idarucizumab received its first global approval, in the USA, in October 2015 for use in adult patients treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. Regulatory applications have been submitted in Canada and in the EU, where it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use. This article summarizes the milestones in the development of idarucizumab leading to this first approval for reversing the anticoagulant effects of dabigatran in adults.
authors.affiliation: Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. dru@adis.com.
authors.forename: Celeste B
authors.initials: CB
authors.lastname: Burness
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000494:pharmacology / Q000627:therapeutic use*; D000931:Antidotes / Q000494:pharmacology / Q000627:therapeutic use; D000991:Antithrombins / Q000009:adverse effects; D001777:Blood Coagulation / Q000187:drug effects; D000069604:Dabigatran / Q000009:adverse effects*; D017277:Drug Approval; D006470:Hemorrhage / Q000139:chemically induced / Q000188:drug therapy*; D006801:Humans
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000931:Antidotes; D000991:Antithrombins; C000594745:idarucizumab; D000069604:Dabigatran