ATLAS Data Not Strong Enough To Support Xarelto’s Use In ACS, FDA Panel Says
This article was originally published in The Pink Sheet Daily
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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Although FDA suggested the sponsor consider a limited duration of use for rivaroxaban in the ACS setting, advisory committee briefing documents reflect doubts about the strength of analyses supporting such a claim.
Broader issue of missing data in clinical trials could see further discussion as FDA’s Cardiovascular and Renal Advisory Committee will relook at Xarelto’s acute coronary syndrome indication Jan. 16, now that J&J has tried to address the missing data that befuddled the committee on the first go-round.