Pradaxa
Author: Jack Allen
Publisher: Datamonitor Healthcare
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Drug Overview
Pradaxa (dabigatran; Boehringer Ingelheim) is an orally available direct thrombin inhibitor (factor IIa inhibitor) indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who previously received treatment with a parenteral anticoagulant for five to 10 days. Pradaxa acts by inhibiting the conversion of fibrinogen into fibrin during the coagulation cascade, and therefore does not allow for the stimulation of platelet activation. Further, through thrombin inhibition, Pradaxa prevents the development of thrombus. Taken together, the drug prevents the formation of blood clots.
TABLE OF CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Pradaxa : Stroke prevention in atrial fibrillation (SPAF)
19 Pradaxa : Venous thromboembolism (VTE)
LIST OF FIGURES
12 Figure 1: Pradaxa for SPAF – SWOT analysis
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Pradaxa for SPAF
14 Figure 3: Datamonitor Healthcare’s drug assessment summary of Pradaxa for SPAF
16 Figure 4: Pradaxa sales for SPAF across the US, Japan, and five major EU markets, by country, 2017–26
26 Figure 5: Pradaxa for venous thromboembolism – SWOT analysis
27 Figure 6: Datamonitor Healthcare’s drug assessment summary of Pradaxa for venous thromboembolism
28 Figure 7: Datamonitor Healthcare’s drug assessment summary of Pradaxa for venous thromboembolism
30 Figure 8: Pradaxa sales forecast for VTE in the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
5 Table 1: Pradaxa drug profile
7 Table 2: Pradaxa pivotal trial data in SPAF
9 Table 3: Pradaxa late-phase trial data in SPAF
11 Table 4: Pradaxa ongoing late-phase clinical trials in SPAF
17 Table 5: Pradaxa sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017–26
19 Table 6: Pradaxa drug profile
21 Table 7: Pradaxa pivotal trial data in venous thromboembolism
23 Table 8: Pradaxa late-phase trial data in venous thromboembolism
25 Table 9: Pradaxa ongoing late-phase clinical trials in venous thromboembolism
31 Table 10: Pradaxa sales for VTE in the US, Japan, and five major EU markets, by country ($m), 2017–26
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