Analyst Outlook
Coumadin (warfarin; Bristol-Myers Squibb) is likely to remain the standard of care for the treatment
of venous thromboembolism (VTE). The drug’s favorable pricing regimen and the availability of a
reversal agent will facilitate its adoption among patients and physicians, with uptake expected to be
especially high in patients who are not suitable for a novel oral anticoagulant (NOAC) regimen.
However, Coumadin is likely to face strong competition from the NOAC drug class in the wider VTE
market; these drugs have demonstrated superior efficacy and safety to Coumadin, along with more
convenient dosing regimens, which could limit Coumadin’s future uptake in the market.
Drug Overview
Coumadin is an orally available vitamin K antagonist (VKA) indicated for the prophylaxis and
treatment of deep vein thrombosis and pulmonary embolism. The drug inhibits the synthesis of
vitamin K-dependent clotting factors such as factors II, VII, IX, and X, and the anticoagulant proteins
C and S. It interferes with clotting factor synthesis by inhibiting the vitamin K epoxide reductase
complex, subunit 1 enzyme, thereby reducing the regeneration of vitamin K1 epoxide, which
ultimately inhibits vitamin K regeneration (FDA, 2011).
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Coumadin : Venous thromboembolism
LIST OF FIGURES
14 Figure 1: Coumadin for venous thromboembolism – SWOT analysis
15 Figure 2: Datamonitor Healthcare’s drug assessment summary of Coumadin for venous
thromboembolism
16 Figure 3: Datamonitor Healthcare’s drug assessment summary of Coumadin for venous
thromboembolism
LIST OF TABLES
4 Table 1: Coumadin drug profile
7 Table 2: Coumadin pivotal trial data in venous thromboembolism