FDA Approves Xarelto (Rivaroxaban) - The First New Oral Anticoagulant Approved to Prevent VTE in Joint Replacement Surgeries in the US

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					          FDA Approves Xarelto (Rivaroxaban) - The First New Oral
        Anticoagulant Approved to Prevent VTE in Joint Replacement
                           Surgeries in the US
        Reference Code: GDHC0039VPT                                                                                                         Publication Date: July 2011


        1         Table of Contents
        1 Table of Contents.................................................................1
        2 Summary .............................................................................2
        3 Overview ..............................................................................2
         3.1 Disease Overview .........................................................2
         3.2 Diagnosis.......................................................................3
         3.3 Epidemiology .................................................................3
         3.4 Current Therapy Options ...............................................3
         3.5 Unmet Need ..................................................................3
         3.6 Xarelto (Rivaroxaban) – The First Once Daily
              Anticoagulant Approved by the FDA for DVT Prevention
                    4
         3.7 RECORD Clinical Trial Results for Venous Blood Clot
              Prevention in Major Orthopedic Surgery .......................4
         3.8 Development and Commercialization ............................5
        4 Appendix ..............................................................................6
         4.1 Methodology ..................................................................6
           4.1.1    Coverage..............................................................6
           4.1.2    Secondary Research ............................................6
           4.1.3    Primary Research ................................................6
           4.1.4    Expert Panel Validation ........................................7
         4.2 Contact Us.....................................................................7
         4.3 Disclaimer......................................................................7




                                                                                                                                                      Market Analysis Alert
FDA Approves Xarelto (Rivaroxaban) - The First New Oral Anticoagulant                                                             GDHC0039VPT /Published JUL 2011/ Page 1
Approved to Prevent VTE in Joint Replacement Surgeries in the US
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                                                                                   demonstrated superior efficacy at the primary endpoint over
                                                                                   enoxaparin. The studies included head-to-head comparisons
        2       Summary                                                            (RECORD-1, 3 and 4), and a comparison of extended-duration
        Deep vein thrombosis (DVT), a form of venous                               (five weeks) Xarelto with short-duration (two weeks) enoxaparin
        thromboembolism (VTE) is a potentially life-threatening                    (RECORD-2). In RECORD-4 Xarelto was tested against
        cardiovascular illness; the third most common after acute                  enoxaparin 30mg injected subcutaneously twice-daily, which is
        coronary syndrome and stroke. In DVT there is a formation of a             an approved treatment regimen for enoxaparin in the US. The
        thrombus (blood clot) within a deep vein, commonly in the thigh            safety profiles were comparable in all four trials, including low
        or calf. If all or part of a clot breaks off, it can travel to the lungs   rates of major bleeding.
        and become a pulmonary embolism (PE) where it can impact                   Xarelto is also under study for the prevention and treatment of a
        the flow of oxygenated blood and lead to potentially life-                 broad range of disorders where blood clotting plays a major role
        threatening consequences and even death. It is estimated that              such as prevention of DVT in patients with atrial fibrillation,
        approximately 600,000 Americans each year suffer from DVT                  stroke and other indications. GlobalData analysis shows that if
        and PE and at least 100,000 deaths may be directly or indirectly           the trial of the drug rivaroxaban is successful in other
        related to these diseases. Apart from this the persons                     indications, rivaroxaban will have the potential to generate
        undergoing procedures are associated with an increased risk of             approximately $3.0 billion annually. The drug will be used in
        developing DVT. According to the American Academy of                       patients susceptible to blood clots while hospitalized for
        Orthopedic Surgeons, more than 800,000 Americans undergo                   illnesses such as cancer and pneumonia. However, Xarelto has
        knee or hip replacement surgery each year and all these are at             to face stiff competition from other drugs including Eliquis
        risk of developing DVT.                                                    (apixaban, approved in the EU) from Pfizer and Bristol-Myers
        The current mainstay treatment for DVT is anticoagulant                    Squibb, edoxaban from Japan's Daiichi Sankyo and Pradaxa
        therapy. Initial therapy involves the use of either unfractionated         (dabigatran), which is already in the market and being sold by
        heparin or low molecular weight (LMW) heparin. The current                 privately held Boehringer Ingelheim.
        standard of care is to administer weight-adjusted LMW heparin
        once daily for a week’s time as an initial treatment. Currently
                                                                                   3       Overview
        enoxaparin, fondaparinux, warfarin, Eliquis (apixaban, approved
                                                                                   3.1    Disease Overview
        in the EU) and Pradexa (dabigatran) are the anticoagulants
        available in the market. Apart from this, other approaches such            Deep vein thrombosis (DVT), a form of venous thromboembolic
        as thrombolysis and the placement of inferior vena cava filters            disease is a condition where there is a formation of a thrombus
        are reserved for severe patients with DVT.                                 (blood cl
				
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Description: FDA Approves Xarelto (Rivaroxaban) - The First New Oral Anticoagulant Approved to Prevent VTE in Joint Replacement Surgeries in the US Summary GlobalData’s report “FDA Approves Xarelto (Rivaroxaban) - The First New Oral Anticoagulant Approved to Prevent VTE in Joint Replacement Surgeries in the US“ provide key insight of the Joint Replacement Surgeries in the US and impact analysis of approval of Rivaroxaban Scope The scope of the report includes - - Impact analysis of the approval of Rivaroxaban first Oral anticoagulant in Joint Replacement Surgeries. Reasons to buy The report will enhance your decision making capability. It will allow you to - - Develop business strategies and perform superior market quantification analysis by - Understanding the trends shaping and driving the global diabetes market . - Understanding treatment preferences of physicians in disease state and across treatment flow.
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