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With European Approval Imminent, J&J/Bayer File Rivaroxaban In The U.S.

This article was originally published in The Pink Sheet Daily

Executive Summary

Novel anticoagulant for orthopedic surgery poised to reach market before Pfizer, Bristol, Astellas and Daiichi Sankyo compounds.

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Rivaroxaban review scheduled

The Cardiovascular and Renal Drugs Advisory Committee will meet March 19 to review Johnson & Johnson/Bayer's novel factor Xa inhibitor Xarelto (rivaroxaban) for prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery, FDA announces. The NDA has a PDUFA date of May 29, 2009. The application is based on four Phase III studies - known as RECORD 1-4 - involving more than 12,500 patients (1"The Pink Sheet" DAILY, July 30, 2008). Bayer launched the oral anticoagulant in Europe in October 2008

Rivaroxaban review scheduled

The Cardiovascular and Renal Drugs Advisory Committee will meet March 19 to review Johnson & Johnson/Bayer's novel factor Xa inhibitor Xarelto (rivaroxaban) for prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery, FDA announces. The NDA has a PDUFA date of May 29, 2009. The application is based on four Phase III studies - known as RECORD 1-4 - involving more than 12,500 patients (1"The Pink Sheet" DAILY, July 30, 2008). Bayer launched the oral anticoagulant in Europe in October 2008

Portola Anticipates "Best In Class" Status For Oral Anticoagulant Betrixaban

Portola Pharmaceuticals is launching a 500-patient Phase II safety and efficacy trial for its novel oral Factor Xa inhibitor anticoagulant betrixaban, touting the compound's potential for three significant areas of differentiation from other late-stage candidates in the crowded anti-thrombotic class

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