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Xarelto Approval For DVT Bodes Well For Coming Indications

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's July 1 approval of Johnson & Johnson's oral anticoagulant comes after a long review process, and in front of some key decision points that will shape the rivaroxaban program's future.

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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.

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.

Xarelto Acute Coronary Syndromes Claim Faces Data Quality Hurdle

FDA will ask its cardio-renal advisory committee whether missing data in J&J/Bayer’s ATLAS study affects the interpretability of rivaroxaban’s demonstrated efficacy in acute coronary syndromes. The panel also will be asked whether the agency should pre-specify clinical trial standards for data quality to reduce the problems associated with missing data in CV outcomes studies.

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