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Bayer/J&J's Xarelto Approval For Stroke Prevention Sets Up Marketing Battle With Pradaxa

This article was originally published in The Pink Sheet Daily

Executive Summary

With an unrestricted label and once-daily dosing, rivaroxaban will do battle with Boehringer-Ingelheim's dabigatran, which is dosed twice a day but can claim superior efficacy to warfarin in the atrial fibrillation population.

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Xarelto Label Expansion Plans Slowed By FDA “Complete Response” On ACS Claim

The agency’s decision not to approve the Factor Xa inhibitor for treating acute coronary syndrome patients follows a negative recommendation by an FDA advisory committee, which was concerned about missing data in the pivotal ATLAS trial. FDA may be seeking more clarity on the issue of missing vital status follow-up for patients who withdrew consent in that study.

Xarelto Label Expansion Plans Slowed By FDA “Complete Response” On ACS Claim

The agency’s decision not to approve the Factor Xa inhibitor for treating acute coronary syndrome patients follows a negative recommendation by an FDA advisory committee, which was concerned about missing data in the pivotal ATLAS trial. FDA may be seeking more clarity on the issue of missing vital status follow-up for patients who withdrew consent in that study.

ATLAS Data Not Strong Enough To Support Xarelto’s Use In ACS, FDA Panel Says

Six of 11 members of the Cardiovascular and Renal Drugs Advisory Committee voted against rivaroxaban’s approval for acute coronary syndromes, saying concerns about missing data in the pivotal trial raised doubts about the efficacy results and could not support creating a new standard of care by adding the Factor Xa inhibitor to dual-antiplatelet therapy.

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