Betrixaban
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| Clinical data | |
|---|---|
| Trade names | Bevyxxa |
| Other names | PRT054021, PRT064445 |
| AHFS/Drugs.com | bevyxxa |
| Routes of administration | By mouth |
| ATC code | |
| Legal status | |
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| Pharmacokinetic data | |
| Protein binding | 60% |
| Elimination half-life | 19–27 hrs |
| Duration of action | ≥72 hrs |
| Excretion | 85% feces, 11% urine |
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Betrixaban (trade name Bevyxxa) is an oral
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
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][non-primary source needed] 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
- Edoxaban
- Enoxaparin
References
- S2CID 35948814.
- ^ "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. Retrieved 2018-10-29.
- PMID 29977164.
- ^ Husten H (24 March 2011). "Merck Abandons Development of Factor Xa Inhibitor Betrixaban". CardioBrief. Retrieved 11 April 2014.
- S2CID 21670373.
- S2CID 25718628.
- PMID 19739042.
- PMID 24576517.
- PMID 23388003.
- PMID 22077144.
- PMID 27232649.
- ^ "FDA approved betrixaban (BEVYXXA, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients". Food and Drug Administration. Retrieved 28 June 2017.
- ^ "Refusal of the marketing authorisation for Dexxience (betrixaban): Outcome of re-examination" (PDF). Committee for Medicinal Products for Human Use (CHMP). European Medicines Agency. 27 July 2018.