in progress with Phase III trials being compared to enoxaparin; NDA filing in 7/08 for prevention of VTE in orthopedic surgery; in Phase III for ACS; NICE recommends drug 3/09; FDA advisory committee votes in favor of short-term use 3/09; PDUFA date 5/29/09; RECORD trial published in Lancet shows superiority to enoxaparin in VTE; Complete response letter indicates FDA requesting more info (5/09); data show that drug may have secondary effects after ACS (6/09); enrollment completed for ROCKET AF study (Xarelto vs warfarin) 9/09 with data expected in 2010; extension-study results show 82% reduction in VTE 11/09; plan to file the first chronic indication , as well as respond to FDA on the "complete response" letter for their application for acute use in hip and knee replacement surgery, in 2H 2010; NICE tech appraisal revised 4/10; positive phase III data, demonstrating non-inferiority to enoxaparin (8/10)
Brand Xarelto Generic rivaroxaban (BAY 59-7939)
Company name Johnson & Johnson , Bayer Product type Speciality
Therapeutic category Cardiovascular agents Key uses Antithrombotic, VTE
Other Uses Acute coronary syndrome Drug Class direct factor Xa inhibitor
Dosage From oral Expected Approval 2011-Q3
FDA Filing 7/08 Last Update date August 09,2010
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