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COMPASS Success Reinforces J&J/Bayer's Broad Labeling Strategy For Xarelto

 
• By Emily Hayes

J&J will be talking to FDA regarding expanded approval for peripheral arterial disease and coronary artery disease following early stop of COMPASS outcomes study; strong data will be needed if asymptomatic patients are targeted.

The early termination of the Phase III COMPASS outcomes study of Johnson & Johnson/Bayer AG's Factor Xa inhibitor Xarelto opens the door for a new arterial disease indication that could mean a new chronic use and a competitive advantage over other novel anticoagulants, if the company succeeds in getting a label change.

Janssen Pharmaceuticals Inc. and partner Bayer, which markets the drug outside the US, announced Feb. 8 that Xarelto (rivaroxaban) met the study's primary endpoint for preventing major cardiovascular events...

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