A new medication to treat blood clots is on the horizon.
Portola Pharmaceuticals’ new drug, betrixaban (Bevyxxa©), was approved by the U.S. Food and Drug Administration (FDA) on June 23. It is part of a class of blood thinning drugs known as direct oral anticoagulants (DOACs) and is a factor Xa inhibitor. Betrixaban was granted a “Fast Track” designation from the FDA, something that is reserved for drugs that offer a significant improvement to disease treatment.
The new drug was specifically created for patients hospitalized with an acute medical illness who are at risk for thrombosis. Patients stuck on bedrest or with limited mobility in the hospital are at risk of developing deep vein thrombosis (DVT) and pulmonary embolism (PE).
“Bevyxxa represents a major advance for the field of thrombosis. It is the first therapy to demonstrate a reduction in the incidence of VTE in these high-risk patients without a significant increase in major bleeding,” said C. Michael Gibson, M.D., APEX Executive Committee Member and Steering Committee Chairman, professor, Harvard Medical School and chairman of the PERFUSE Study Group in a press release. “With this approval, we are finally able to help protect these patients from this often fatal, yet preventable condition.”
Betrixaban was tested in the APEX study. The study compared oral betrixaban for 35 to 42 days with injectable enoxaparin for 6 to 14 days, followed by a placebo, to measure its effectiveness in preventing VTE. According to the press release, “Bevyxxa reduced the incidence of DVT and PE blood clots compared with those taking enoxaparin plus placebo (4.4 percent vs. 6.0 percent; relative risk 0.75, 95 percent CI: 0.61, 0.91) with no significant increase in major bleeding (0.67 percent vs. 0.57 percent).”
“For the first time, physicians will have a therapy to help reduce VTE in acutely ill medical patients during their transition from hospital to home, which may ultimately help reduce morbidity,” said Alexander (Ander) T. Cohen, M.B.B.S., M.Sc., M.D., FRACP, APEX Co-Principal Investigator and Co-Chairman of the APEX Executive Committee and Consultant Physician at Guy’s and St Thomas’ NHS Foundation.
Betrixaban is expected to be launched between August and November 2017.
A full look at the APEX study can be found in the New England Journal of Medicine.
To learn more about betrixaban, register to attend the FREE NATF CME educational program on December 2, 2016 in Boston, MA by clicking here. (link to www.regonline.com/VTEBoston)