FDA Advisory Committee Meeting to Review Rivaroxaban NDA

The FDA's Cardiovascular and Renal Drugs Advisory Committee will have a meeting today to review the New Drug Application in the USA for rivaroxaban.

The FDA's Cardiovascular and Renal Drugs Advisory Committee has scheduled a meeting for September 8, 2011, to review the New Drug Application in the USA for rivaroxaban in the prevention of stroke and non-CNS systemic embolism in patients with atrial fibrillation.

In preparation for the meeting, the FDA reviewers have suggested that data from the ROCKET AF trial comparing rivaroxaban to warfarin do not show whether rivaroxaban is as effective for its proposed indication in comparison to warfarin when the latter is used skillfully. In addition, the FDA reviewers have stated that the proposed instructions for the transition from rivaroxaban to warfarin have not been evaluated in a clinical study.

As outlined in the submission package that Bayer's d