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A Cardiovascular and Renal Drugs Advisory Committee meeting convenes today (September 8) 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.
The US Food and Drug Administration (FDA) will suggest that data from the ROCKET AF trial comparing rivaroxaban to warfarin does 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 will state that the proposed instructions for the transition from rivaroxaban to warfarin have not been evaluated in a clinical study.
Manufacturers Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development will argue that the results of the ROCKET AF study properly demonstrate a favourable benefit risk balance for rivaroxaban compared to warfarin, reducing stroke and non-CNS systemic embolism, with low and comparable bleeding rates.
They will also claim that excess bleeding did not occur with rivaroxaban in ROCKET, and there are no other safety concerns that preclude approval.
In ROCKET AF, rivaroxaban was associated with significantly fewer of the most concerning bleeds, including intracranial haemorrhages, critical organ bleeds, and bleeding-related deaths compared to warfarin, Bayer will argue.
All-cause mortality trended in favour of rivaroxaban and the results were achieved in a unique patient population with a higher risk for recurrent thromboembolic events with a rigorous double-blind methodology, they will add.
The increase in events observed following discontinuation of study drug in the rivaroxaban arm was considered likely due to the double blind design of the ROCKET AF study, and not to the drug itself.
“We are looking forward to an open and productive discussion during the FDA Advisory Committee Meeting and are confident in the results of ROCKET AF,” said Dr Kemal Malik, Member of the Bayer HealthCare Executive Committee and Chief Medical Officer.
The Advisory Committee will consider the Sponsors’ presentation, the FDA presentation, and the questions posed by the FDA, and their subsequent recommendation will be assessed by the FDA in its review of the New Drug Application for rivaroxaban. A decision by the FDA is expected in early November 2011.