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FDA Approves Reversal Agent for Pradaxa
Idarucizumab (Praxbind, Boehringer Ingelheim) has received FDA approval for patients treated with dabigatran etexilate (Pradaxa, Boehringer Igelheim) when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery, for urgent procedures, or in life-threatening or uncontrolled bleeding. The product had been granted breakthrough therapy and priority review designations and was approved under an accelerated approval pathway.
Approval was based on results of studies and an interim analysis that found that idarucizumab’s reversal effects were evident within minutes after administration of 5 g of the reversal agent.
Boehringer Ingelheim is continuing to evaluate the product in RE-VERSE AD, a phase III global study that includes patients taking dabigatran etexilate who have uncontrolled bleeding or require emergency procedures. The study, the first of its kind in patients, has been under way since May 2014, enrolling patients in more than 35 countries.
Idarucizumab is a humanized antibody fragment designed as a specific reversal agent to dabigatran. It binds specifically to dabigatran molecules only, neutralizing their anticoagulant effect without interfering with the coagulation cascade.
Currently approved indications for dabigatran are prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and a risk factor for stroke, primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery, and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and recurrent PE in adults.
Source: Boeringer Ingelheim, October 19, 2015.