Boehringer Ingelheim submitted idarucizumab for approval of marketing authorization to the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA) and Health Canada. The submission is directed to patients who require rapid reversal of the anticoagulant effect of dabigatran, the active ingredient in Boehringer Ingelheim’s Pradaxa.
Pradaxa, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases. However, specific antidotes are not yet available for these agents to manage life-threatening bleeding or when emergency surgery is necessary. Idarucizumab is a specific antibody fragment which binds dabigatran with high affinity and thereby prevents dabigatran’s inhibition of thrombin.
Professor Jörg Kreuzer, Vice President of Medicine Therapeutic Area Cardiovascular, Boehringer Ingelheim, stated: “The submissions for idarucizumab mark the first regulatory submissions for a specific reversal agent to a novel oral anticoagulant. Our discovery and development of idarucizumab in-house is an example of our company’s dedication to the evolution and innovation of anticoagulation care.