Johnson & Johnson has submitted a new drug application (NDA) to the FDA for its oral anticoagulant rivaroxaban, indicated to prevent stroke and systemic embolism in non-valvular atrial fibrillation (AF) patients.
The Raritan, N.J.-based company said that the application was submitted with support data from the phase III ROCKET AF (Rivaroxaban Once daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) study.
The results, presented at last year’s American Heart Association sessions, showed that rivaroxaban was non-inferior to warfarin for the prevention of stroke and non-CNS systemic embolism, and did not achieve superiority by the intention-to-treat analysis.
The 14,269 patients enrolled in the trial received either a 20 mg daily dose of rivaroxaban or dose-adjusted warfarin with a target INR range of 2.5. Results showed that there were 1.71 events per 100 patient-years (188 patients) in patients treated with rivaroxaban and 2.16 events per 100 patient-years (241 patients) in patients treated with warfarin.
However, some have cautioned that the benefits of the drug remain unclear. Elaine M. Hylek, MD, of the Boston University School of Medicine, commented that the safety profile may not be clear and that because the intention-to-treat results showed no significance in superiority it may reflect the differences in effectiveness between the two drugs.
In addition to the NDA submitted, Johnson & Johnson said that it is also looking to gain approval for rivaroxaban for the prevention of deep vein thrombosis and pulmonary embolism in patients who are undergoing a total hip or knee replacement.
This NDA was submitted with data support from the RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) trial.