Rivaroxaban FDA review of ROCKET AF data

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Overview

The FDA conducted an advisory committee review regarding the approvability of rivaroxaban for reduction of stroke and systemic embolization in patients with non-valvular atrial fibrillation on September 8th, 2011.

Non Inferiority Margin

An upper bound of the 95% CI of the hazard ratio was set at 1.38 by the FDA to establish non-inferiority. In no subgroup did the comparison come near the non-inferiority margin, and non-inferiority was clearly observed in all treatment subgroups and in all forms of analysis.