Betrixaban Explained

Betrixaban (trade name Bevyxxa) is an oral anticoagulant drug which acts as a direct factor Xa inhibitor.[1] Betrixaban is FDA approved for venous thrombosis prevention in adults hospitalized for an acute illness who are at risk for thromboembolic complications.[2] Compared to other directly acting oral anticoagulants betrixaban has relatively low renal excretion and is not metabolized by CYP3A4.[3]

History

Betrixaban was originally developed by Millennium Pharmaceuticals. Portola Pharmaceuticals acquired rights for betrixaban in 2004 and co-developed it with Merck. In 2011 Merck discontinued joint development.[4]

The drug has undergone clinical trials for prevention of embolism after knee surgery[5] and for prevention of stroke following non-valvular atrial fibrillation.[6] [7] Betrixaban was also studied in a large phase III clinical trial for extended duration thromboprophylaxis in acute ill patients.[8] Previously apixaban and rivaroxaban have failed to show positive risk/benefit ratio in this indication compared to enoxaparin.[9] [10] APEX trial compared betrixaban with enoxaparin and included 7513 patients. Lower rate of VTE events was found in betrixaban arm with no increase in major bleedings compared to enoxaparin.[11] Based on these results betrixaban was approved by FDA on June 23, 2017, becoming the first DOAC approved for extended prophylaxis in hospitalized patients.[12]

Betrixaban has been also reviewed by EMA but didn't receive marketing approval in EU mainly due to concerns of increased bleeding risk and absence of reversal agent.[13]

See also

Notes and References

  1. Eriksson BI, Quinlan DJ, Weitz JI . Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor xa inhibitors in development . Clinical Pharmacokinetics . 48 . 1 . 1–22 . 2009 . 19071881 . 10.2165/0003088-200948010-00001 . 35948814 .
  2. Web site: Approved Drugs - FDA approved betrixaban (BEVYXXA, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients. Center for Drug Evaluation and Research (CDER) . U.S. Food and Drug Administration . en. 2018-10-29.
  3. Huisman MV, Klok FA . Pharmacological properties of betrixaban . European Heart Journal Supplements . 20 . Suppl E . E12–E15 . May 2018 . 29977164 . 6016700 . 10.1093/eurheartj/suy016 .
  4. Web site: Merck Abandons Development of Factor Xa Inhibitor Betrixaban. Husten H . 24 March 2011 . CardioBrief. 11 April 2014.
  5. Turpie AG, Bauer KA, Davidson BL, Fisher WD, Gent M, Huo MH, Sinha U, Gretler DD . 6 . A randomized evaluation of betrixaban, an oral factor Xa inhibitor, for prevention of thromboembolic events after total knee replacement (EXPERT) . Thrombosis and Haemostasis . 101 . 1 . 68–76 . January 2009 . 19132191 . 10.1160/th08-07-0460 . 21670373 .
  6. Piccini JP, Lopes RD, Mahaffey KW . Oral factor Xa inhibitors for the prevention of stroke in atrial fibrillation . Current Opinion in Cardiology . 25 . 4 . 312–320 . July 2010 . 20520539 . 10.1097/HCO.0b013e32833a524f . 25718628 .
  7. Sobieraj-Teague M, O'Donnell M, Eikelboom J . New anticoagulants for atrial fibrillation . Seminars in Thrombosis and Hemostasis . 35 . 5 . 515–524 . July 2009 . 19739042 . 10.1055/s-0029-1234147 . free .
  8. Cohen AT, Harrington R, Goldhaber SZ, Hull R, Gibson CM, Hernandez AF, Kitt MM, Lorenz TJ . 6 . The design and rationale for the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban (APEX) study . American Heart Journal . 167 . 3 . 335–341 . March 2014 . 24576517 . 10.1016/j.ahj.2013.11.006 . free .
  9. Cohen AT, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos AC, Tapson V . 6 . Rivaroxaban for thromboprophylaxis in acutely ill medical patients . EN . The New England Journal of Medicine . 368 . 6 . 513–523 . February 2013 . 23388003 . 10.1056/nejmoa1111096 . free . 10447/96593 .
  10. Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI . Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients . EN . The New England Journal of Medicine . 365 . 23 . 2167–2177 . December 2011 . 22077144 . 10.1056/nejmoa1110899 . free . 2437/127244 .
  11. Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, Hernandez AF, Gibson CM . 6 . Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients . EN . The New England Journal of Medicine . 375 . 6 . 534–544 . August 2016 . 27232649 . 10.1056/nejmoa1601747 . free . 11573/884978 . free .
  12. Web site: FDA approved betrixaban (BEVYXXA, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients. . 28 June 2017.
  13. Web site: Refusal of the marketing authorisation for Dexxience (betrixaban): Outcome of re-examination . Committee for Medicinal Products for Human Use (CHMP) . European Medicines Agency . 27 July 2018 .

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