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Doctor and hospitalized patient
The oral, once-daily factor Xa inhibitor betrixaban (Bevyxxa®) was granted approval by the US Food and Drug Administration (FDA) under priority review.
Betrixaban is the first and only anticoagulant for hospital and extended duration prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness at risk for thromboembolic complications due to restricted mobility and other risk factors for VTE, according to Portola Pharmaceuticals, Inc, the drug’s developer.
Betrixaban had also received fast track designation from the FDA.
Betrixaban is Portola’s first commercial product.
The FDA approved betrixaban based on data from the phase 3 APEX trial, a randomized, double-blind multinational clinical trial comparing extended duration betrixaban to short duration of enoxaparin.
The trial enrolled 7513 patients at more than 450 clinical sites worldwide. The patients were acutely ill with medical conditions, hospitalized, and had risk factors for VTE.
Patients who received betrixaban had an initial dose of 160 mg orally on day 1, 80 mg once daily for 35 to 42 days, and a placebo injection once daily for 6 to 14 days.
Patients who received enoxaparin had a 40 mg injection subcutaneously once daily for 6 to 14 days and a placebo pill orally once daily for 35 to 42 days.
Efficacy data was analyzed in 7441 patients and assessed by a composite outcome score comprising either the occurrence of asymptomatic proximal deep vein thrombosis (DVT) or symptomatic DVT, non-fatal pulmonary embolism (PE), or VTE-related death.
Investigators observed fewer events in patients receiving betrixaban (4.4%) compared with those taking enoxaparin (6%) (relative risk 0.75, 95% CI: 0.61, 0.91) with no significant increase in major bleeding (0.67% vs 0.57%, respectively).
The most common adverse reactions with betrixaban occurring in 5% or more of patients were related to bleeding.
Overall, 54% of patients receiving betrixaban experienced at least one adverse reaction compared with 52% taking enoxaparin.
The frequency of patients reporting serious adverse reactions was similar between betrixaban (18%) and enoxaparin (17%).
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.
The incidence rate for major bleeding episodes was 0.67% and 0.57% for betrixaban and enoxaparin, respectively.
Portola expects to launch betrixaban between August and November 2017.
The European Medicines Agency’s Committee for Human Medicinal Products (CHMP) is reviewing betrixaban for marketing authorization under its standard review period.
Portola is also advancing clinical development of andexanet alfa (AndexXa®) and cerdulatinib.
Andexanet alfa is a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable factor Xa inhibitor.
Cerdulatinib is a Syk/JAK inhibitor to treat hematologic cancers.
See the full prescribing information for more details on betrixaban.
