FDA Approves Venous Thromboembolism Prophylaxis

Officials with the FDA have approved betrixaban (Bevyxxa, Portola Pharmaceuticals), the first and only anticoagulant for hospital and extended duration prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

Bevyxxa has been approved based on data from Portola's phase 3 APEX Study, which enrolled 7,513 patients at more than 450 clinical sites worldwide. The APEX study evaluated oral betrixaban for 35 to 42 days compared with injectable enoxaparin for 6 to 14 days followed by placebo in assessing the prevention of VTE in high-risk acutely ill medical patients. As detailed in the prescribing information, Bevyxxa efficacy was measured in the modified intent-to-treat (mITT) analysis, which includes 7,441 patients assessed by a composite outcome score comprising either the occurrence of asymptomatic proximal deep vein thrombosis (DVT) or symptomatic DVT, non-fatal PE or VTE-related death.

Betrixaban reduced the incidence of DVT and PE blood clots compared with those taking enoxaparin plus placebo (4.4% vs. 6.0%; relative risk 0.75, 95 percent CI: 0.61, 0.91) with no significant increase in major bleeding (0.67% vs. 0.57%). The most frequent reason for treatment discontinuation was bleeding, with an incidence rate for all bleeding episodes of 2.4% and 1.2% for betrixaban and enoxaparin, respectively.

Results from the APEX Study have been peer-reviewed and published in The New England Journal of Medicine.¹

Reference

Cohen, AT, Harrington RA, Goldhaber SZ, et al. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med. 2016; 375.6