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Novel blood clot drug Xarelto filed in U.S.

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Johnson & Johnson and Bayer file an NDA for Xarelto (rivaroxaban) July 29, following a positive recommendation July 25 by the EMEA's Committee for Medicinal Products for Human Use. The once-daily Factor Xa inhibitor is indicated for prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery. If approved, the sponsors are hoping Xarelto's superior efficacy and safety profile from four Phase III studies in more than 12,500 patients would give it a leg up over warfarin and enoxaparin (Sanofi-Aventis' Lovenox) (1Pharmaceutical Approvals Monthly October 2007, p. 13). Xarelto's estimated user fee date is May 29, 2009

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