FDA Approves Bevyxxa for Hospital and Extended-Duration VTE Prevention in Acutely Ill Patients
June 28, 2017—Portola Pharmaceuticals Inc. recently announced that the US Food and Drug Administration (FDA) has approved Bevyxxa (betrixaban) for hospital and extended-duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications caused by moderate or severe restricted mobility and other risk factors for VTE. Bevyxxa is an oral, once-daily factor Xa inhibitor.
Portola expects to launch Bevyxxa in the United States between August and November 2017. The company advised that in the European Union, the European Medicines Agency’s Committee for Human Medicinal Products is reviewing the marketing authorization application for betrixaban under its standard review period.
According to the Portola, Bevyxxa was granted fast track designation, which is given to drugs that may offer significant improvements in treatment or provide a treatment where no adequate therapy exists, and was approved by the FDA under priority review status. Bevyxxa has been approved based on data from Portola's pivotal phase 3 APEX study, which enrolled 7,513 patients at more than 450 clinical sites worldwide.
The company noted that 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. Bevyxxa efficacy was measured in the modified intent-to-treat analysis, which included 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 pulmonary embolism, or VTE-related death.
Bevyxxa reduced the incidence of DVT and pulmonary embolism blood clots compared with those taking enoxaparin plus placebo (4.4% vs 6%; relative risk 0.75; 95% confidence interval, 0.61 to 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.
In Portolo's announcement, C. Michael Gibson, MD, APEX Executive Committee Member and Steering Committee Chairman, commented, "Bevyxxa represents a major advance in 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. With this approval, we are finally able to help protect these patients from this often fatal, yet preventable condition.”
Alexander T. Cohen, MD, APEX Co-Principal Investigator and Co-Chairman of the APEX Executive Committee added, “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.”