The US Food and Drug Administration (FDA) has approved betrixaban (Bevyxxa, Portola), the first and only anticoagulant for hospital and extended duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in adult patients hospitalised 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 approved by the FDA under 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. Betrixaban 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 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, betrixaban 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 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%; relative risk 0.75, 95% 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.
“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,” says Alexander Cohen, APEX co-principal investigator and co-chairman of the APEX executive committee and consultant physician at Guy’s and St Thomas’ NHS Foundation, London, UK.
According to a press release, Portola expects to launch betrixaban between August and November 2017.
In the EU, the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) is reviewing the marketing authorisation application for betrixaban under its standard review period.