Janssen Looks To Differentiate Anticoagulant Xarelto With Broad Label
With positive data now in for Xarelto’s ability to treat and prevention recurrence of VTE, Janssen looks to file for a fourth indication for the novel anticoagulant, positioning the drug to crack a promising market that may be under-appreciated.
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COMPASS Success Reinforces J&J/Bayer's Broad Labeling Strategy For Xarelto
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.
Xarelto Indication Expansion Efforts Show That Fewer Could Be More
J&J and Bayer continue quest for acute coronary syndrome claim following three rejections by FDA; this time, Xarelto will be tested on top of only one antiplatelet drug instead of two.
Xarelto Falters Again In ACS Bid, As Competitors Aim To Catch Up To J&J Drug’s Label
FDA’s third rejection of J&J’s attempt to expand use of Xarelto to ACS patients comes as competing oral anticoagulants await agency action on pending applications that could match Xarelto’s breadth of approved indications.