Rivaroxaban is a novel oral anticoagulant being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role.
Rivaroxaban is being developed jointly by J&JPRD and Bayer HealthCare.
MAGELLAN clinical trial is a double blind, double-dummy study which evaluated 8,100 acutely ill medical patients from 54 countries, who had been completely immobilized for at least one day during hospitalization.
Further, the study evaluated the non-inferiority of oral rivaroxaban for VTE prophylaxis compared to subcutaneous enoxaparin in this patient population at 10 days.
In the study, rivaroxaban met its primary clinical efficacy objectives of demonstrating non-inferiority to enoxaparin in short-term use (10 ± 4 days), and superiority in long-term use (35 ± 4 days) when compared to short-term use of enoxaparin followed by placebo.
J&JPRD Cardiovascular Development vice president Peter DiBattiste said as with all anticoagulants, the benefits need to be evaluated in light of the bleeding results, and they are conducting additional analyses to help better understand which patients in this population may benefit most from treatment with rivaroxaban.
The company’s US filing strategy in this indication is under review, and will depend upon the outcome of our further analyses of the study.