Cardiovascular and Renal Drugs Advisory Committee recommends FDA approval of J&JPRD's rivaroxaban

Sep 9 2011

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended approval of rivaroxaban, a novel, once-daily, oral anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). The committee voted 9-2 in favor of rivaroxaban in patients with AF who are at risk of stroke and systemic embolism.

"We are pleased with the committee's recommendation and look forward to working with the FDA to help make this important therapy available in the U.S.," said Peter M. DiBattiste, M.D., Global Therapeutic Area Head, Cardiovascular and Metabolism, J&JPRD.

Data presented at today's advisory committee meeting included results from the pivotal, global, double-blind Phase 3 ROCKET AF (Rivaroxaban Once-daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for the prevention of stroke and Embolism Trial in Atrial Fibrillation) clinical trial, which demonstrated that once-daily rivaroxaban had a 21% relative risk reduction in stroke and non-CNS systemic embolism while on-treatment compared to warfarin, with low and comparable bleeding rates^.

ROCKET AF compared oral, once-daily rivaroxaban with dose-adjusted warfarin in 14,264 patients with non-valvular AF who are at risk for stroke and non-CNS systemic embolism. The study was designed to first demonstrate that rivaroxaban was non-inferior to warfarin (the study's primary efficacy endpoint). Once non-inferiority was established, data was assessed for superiority with an "on-treatment" population (i.e., patients on study drug and followed for events while on the drug for duration of the trial). The analysis for superiority was pre-specified. An additional confirmatory analysis was also performed in the intention to treat (ITT) population and including data to the end of the study. This group included all randomized patients followed for events, including periods both on and off treatment, until trial completion.

Recommendations from the advisory committee will be considered by the FDA in its review of the New Drug Application for rivaroxaban in this indication that was submitted by J&JPRD on January 5, 2011, but are not bound to directly follow them. If approved by the FDA, Janssen Pharmaceuticals, Inc. will commercialize rivaroxaban in the U.S.

Source: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.