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

 
• By Sue Sutter

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.

Concerns about missing data in the pivotal ATLAS trial led the majority of FDA’s Cardiovascular and Renal Drugs Advisory Committee to recommend against approval of Johnson & Johnson/Bayer HealthCare AG’s Factor Xa inhibitor Xarelto (rivaroxaban) for combination use with dual-antiplatelet therapy for treatment of acute coronary syndromes.

In their May 23 meeting, the committee voted 6-4, with one abstention, that rivaroxaban should not be approved for use in the treatment of ACS. Panel members voting against approval...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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AMR-Targeting Drug Secures EMA PRIME Designation

 
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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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