Drugs Xagena
Pradaxa ( Dabigatran etexilate ) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis ( DVT ) and pulmonary embolism ( PE ).
The FDA ( Food and Drug Administration ) approved Pradaxa for DVT and PE patients earlier this year.
The approval by the European Commission follows the positive opinion issued by the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ), and is based on results from three robust phase III clinical trials that demonstrated the efficacy of Dabigatran etexilate in the treatment and prevention of repeat deep vein thrombosis and PE compared to Warfarin ( Coumadin ).
In a fourth trial, data showed a 92% reduction in the risk of recurrent blood clots in patients treated with Dabigatran etexilate compared to placebo.
With regards to safety, results showed that deep vein thrombosis or pulmonary embolism patients taking Dabigatran etexilate experienced significantly lower rates of bleeding than those taking Warfarin, resulting in a favourable overall safety profile.
Pradaxa is convenient for patients as it does not require routine dose monitoring, nor a mandatory dose change during the course of treatment.
Deep vein thrombosis and pulmonary embolism patients can start taking Pradaxa in a simple fixed dose regimen after initial treatment with an injectable anticoagulant such as low-molecular-weight heparin ( LMWH ).
Clinical experience of Pradaxa equates to over 2.9 million patient-years in all licensed indications worldwide. Pradaxa has already been available for more than six years and is approved in over 100 countries to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation ( NVAF ).
Pradaxa 150mg bid is the only NOAC ( new oral anticoagulant ), study of which ( RE-LY ) has shown a significant reduction in the incidence of both ischaemic and haemorrhagic strokes versus Warfarin in patients with non-valvular atrial fibrillation.
Ischaemic strokes, which account for nine out of 10 strokes experienced by patients with atrial fibrillation, can have devastating consequences and are often fatal or severely disabling.
RE-LY was a global, phase III, PROBE ( prospective, randomized, open-label with blinded endpoint evaluation ) design trial comparing two fixed doses of the oral direct thrombin inhibitor Dabigatran etexilate ( 110mg and 150mg bid ) each administered in a blinded manner, with open label Warfarin.
Dabigatran etexilate 110mg bid showed non-inferior efficacy versus Warfarin for reducing risk of stroke.
Currently approved indications for Pradaxa are: a) prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke; b) primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery; c) primary prevention of venous thromboembolic events in patients undergoing elective total knee replacement surgery; d) treatment of deep vein thrombosis and pulmonary embolism and the prevention of recurrent DVT and PE in adults.
In the U.S. Pradaxa is approved: a) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; b) for the treatment of deep vein thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for five to 10 days; c) to reduce the risk of recurrence of deep vein thrombosis and pulmonary embolism in patients who have been previously treated.
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.
Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for thrombus formation.
In contrast to vitamin-K antagonists, which variably act via different coagulation factors, Pradaxa provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or mandatory dose adjustment. ( Xagena )
Source: Boehringer-Ingelheim, 2014
XagenaMedicine_2014
