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Xarelto to reduce risk of stroke

Trials on Xarelto demonstrated superiority to warfarin in reducing the risk of stroke and non-CNS systemic embolism in patients with AF

Late-stage trials on Bayer and Johnson & Johnson's Xarelto (rivaroxaban) have demonstrated superiority to warfarin in reducing the risk of stroke and non-CNS systemic embolism in patients with atrial fibrillation (AF).

In the phase III Rocket AF trial, Xarelto also demonstrated "comparable major and non-major clinically relevant bleeding" compared to warfarin.

The results presented at the American Heart Association Scientific Sessions 2010 adds Xarelto to the growing list of new drugs that seem to be at least as good as warfarin – the current treatment to prevent strokes in AF.

The trial is the largest double-blind study of its kind and monitored 14,264 patients with non-valvular AF at risk of stroke and systemic embolism. Data showed those taking once-daily Xarelto versus those on dose-adjusted warfarin were 21 per cent less likely to suffer a stroke or embolism.

The rate of major bleeding was 3.6 per cent for patients on Xarelto, compared to 3.5 per cent taking warfarin. Bleeding events most concerning to physicians and patients, including intracranial haemorrhage, critical organ bleed, and bleeding-related death were significantly lower in patients who took Xarelto.

Professor Werner Hacke, chair of the department of neurology at the Universty of Heidelberg, Germany said: "The ROCKET AF study has shown that once-daily rivaroxaban promises patients improved protection from stroke with good safety and added convenience."

Johnson & Johnson plans to file for US regulatory approval of Xarelto before the end of the year and Bayer plans to do the same in Europe. Conservative predictions estimate that Xarelto could generate annual revenue exceeding $2.7bn in a market that could surpass $14bn annually.

16th November 2010

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