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Stroke drug submitted for EU/US approval

Rivaroxaban has been submitted for marketing approval in the EU by Bayer and the US by J&J for the prevention of stroke in patients with AF

Rivaroxaban has been submitted for marketing approval in both the EU and the US for the prevention of stroke in patients with atrial fibrillation (AF).

The drug is co-developed by Johnson and Johnson (J&J) and Bayer, with J&J covering US marketing and Bayer covering the EU and other areas outside the US.

Both companies also submitted requests in their respective regions for marketing approval for the use of rivaroxaban in further areas, with Bayer requesting approval for the drug's use in treating deep vein thrombosis (DVT) and the prevention of recurrent DVT and pulmonary embolism (PE).

J&J's application also requested rivaroxaban's approval for the prevention of DVT, as well as the prevention of PE in patients undergoing total hip or total knee replacement surgery.

Both submissions for the drug's use in the prevention of stroke in people with AF are based on the phase III ROCKET AF trial involving over 14,000 patients. The study demonstrated rivaroxaban's superiority to current treatment, and fellow anticoagulant, warfarin in reducing the risk of stroke and non-CNS systemic embolism in patients with AF.

Bayer's request for rivaroxaban's approval in the treatment of DVT and the prevention of recurrent DVT and PE are based on positive results from the phase III EINSTEIN-DVT and EINSTEIN-Extension trials.

Rivaroxaban is already marketed as Xarelto for use in the prevention of venous thromboembolism (VTE) in patients following hip or knee replacement surgery.

5th January 2011

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