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to prevent thrombosis after
knee replacement surgery
© Boehringer Ingelheim
The European Commission (EC) has granted marketing authorization for idarucizumab (Praxbind), a humanized antibody fragment designed to reverse the anticoagulant effects of dabigatran etexilate (Pradaxa) in cases of emergency surgery/urgent procedures or in situations of life-threatening or uncontrolled bleeding.
The EC’s decision applies to the 28 countries of the European Union (EU) as well as Iceland, Lichtenstein, and Norway.
Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant to be approved for use in the EU. The drug was approved in the US last month.
The EC’s decision to approve idarucizumab was based on results in healthy volunteers and an interim analysis of the phase 3 RE-VERSE AD trial.
In the study of healthy volunteers, the pharmacokinetic profile of idarucizumab met the requirement for rapid peak exposure and rapid elimination, with no effect on pharmacodynamic parameters. And researchers said the drug was well-tolerated.
In RE-VERSE AD, researchers evaluated idarucizumab in emergency settings. The drug normalized diluted thrombin time and ecarin clotting time in a majority of dabigatran-treated patients with uncontrolled or life-threatening bleeding complications and most patients who required emergency surgery or an invasive procedure.
The researchers said there were no safety concerns related to idarucizumab. However, 23% of patients in this trial experienced serious adverse events, 20% of patients died, and several patients had thrombotic or bleeding events.
Boehringer Ingelheim, the company developing idarucizumab, said it is committed to making the drug available as widely as possible and will launch idarucizumab in European countries as soon as national requirements allow.
Boehringer Ingelheim is also the maker of dabigatran, which is currently approved in the EU for the following indications:
- Prevention of stroke and systemic embolism in patients with non-valvular 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
- Treatment of deep vein thrombosis and pulmonary embolism and the prevention of recurrent deep vein thrombosis and pulmonary embolism in adults.
to prevent thrombosis after
knee replacement surgery
© Boehringer Ingelheim
The European Commission (EC) has granted marketing authorization for idarucizumab (Praxbind), a humanized antibody fragment designed to reverse the anticoagulant effects of dabigatran etexilate (Pradaxa) in cases of emergency surgery/urgent procedures or in situations of life-threatening or uncontrolled bleeding.
The EC’s decision applies to the 28 countries of the European Union (EU) as well as Iceland, Lichtenstein, and Norway.
Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant to be approved for use in the EU. The drug was approved in the US last month.
The EC’s decision to approve idarucizumab was based on results in healthy volunteers and an interim analysis of the phase 3 RE-VERSE AD trial.
In the study of healthy volunteers, the pharmacokinetic profile of idarucizumab met the requirement for rapid peak exposure and rapid elimination, with no effect on pharmacodynamic parameters. And researchers said the drug was well-tolerated.
In RE-VERSE AD, researchers evaluated idarucizumab in emergency settings. The drug normalized diluted thrombin time and ecarin clotting time in a majority of dabigatran-treated patients with uncontrolled or life-threatening bleeding complications and most patients who required emergency surgery or an invasive procedure.
The researchers said there were no safety concerns related to idarucizumab. However, 23% of patients in this trial experienced serious adverse events, 20% of patients died, and several patients had thrombotic or bleeding events.
Boehringer Ingelheim, the company developing idarucizumab, said it is committed to making the drug available as widely as possible and will launch idarucizumab in European countries as soon as national requirements allow.
Boehringer Ingelheim is also the maker of dabigatran, which is currently approved in the EU for the following indications:
- Prevention of stroke and systemic embolism in patients with non-valvular 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
- Treatment of deep vein thrombosis and pulmonary embolism and the prevention of recurrent deep vein thrombosis and pulmonary embolism in adults.
to prevent thrombosis after
knee replacement surgery
© Boehringer Ingelheim
The European Commission (EC) has granted marketing authorization for idarucizumab (Praxbind), a humanized antibody fragment designed to reverse the anticoagulant effects of dabigatran etexilate (Pradaxa) in cases of emergency surgery/urgent procedures or in situations of life-threatening or uncontrolled bleeding.
The EC’s decision applies to the 28 countries of the European Union (EU) as well as Iceland, Lichtenstein, and Norway.
Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant to be approved for use in the EU. The drug was approved in the US last month.
The EC’s decision to approve idarucizumab was based on results in healthy volunteers and an interim analysis of the phase 3 RE-VERSE AD trial.
In the study of healthy volunteers, the pharmacokinetic profile of idarucizumab met the requirement for rapid peak exposure and rapid elimination, with no effect on pharmacodynamic parameters. And researchers said the drug was well-tolerated.
In RE-VERSE AD, researchers evaluated idarucizumab in emergency settings. The drug normalized diluted thrombin time and ecarin clotting time in a majority of dabigatran-treated patients with uncontrolled or life-threatening bleeding complications and most patients who required emergency surgery or an invasive procedure.
The researchers said there were no safety concerns related to idarucizumab. However, 23% of patients in this trial experienced serious adverse events, 20% of patients died, and several patients had thrombotic or bleeding events.
Boehringer Ingelheim, the company developing idarucizumab, said it is committed to making the drug available as widely as possible and will launch idarucizumab in European countries as soon as national requirements allow.
Boehringer Ingelheim is also the maker of dabigatran, which is currently approved in the EU for the following indications:
- Prevention of stroke and systemic embolism in patients with non-valvular 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
- Treatment of deep vein thrombosis and pulmonary embolism and the prevention of recurrent deep vein thrombosis and pulmonary embolism in adults.