The FDA has approved betrixaban (Bevyxxa, Portola Pharmaceuticals), the first anticoagulant for hospital and extended-duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in adults 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.
Betrixaban, an oral, once-daily factor Xa inhibitor, was granted a fast track designation and was approved by the FDA under a priority review, which is a status given to drugs that may offer significant improvements in treatment or provide a treatment where no adequate therapy exists.
The FDA’s approval was based on data from the pivotal phase 3 APEX trial, which evaluated oral betrixaban (administered for 35 to 42 days) compared with injectable enoxaparin (administered for 6 to 14 days) followed by placebo in assessing the prevention of VTE in high-risk, acutely ill medical patients. The efficacy of betrixaban was measured in 7,441 patients, who were assessed by a composite outcome score consisting of either the occurrence of asymptomatic proximal deep-vein thrombosis (DVT) or symptomatic DVT, nonfatal pulmonary embolism (PE), or VTE-related death.
Betrixaban reduced the incidence of DVT and PE blood clots compared with enoxaparin plus placebo (4.4% vs. 6.0%, respectively; relative risk: 0.75), with no significant increase in major bleeding (0.67%vs. 0.57%). The most common reason for treatment discontinuation was bleeding, with incidence rates for all bleeding episodes of 2.4% and 1.2% for betrixaban and enoxaparin, respectively.
Betrixaban is expected be launched in the U.S. between August and November 2017.
Source: Portola Pharmaceuticals; June 23, 2017.