Xarelto Review Sparks Debate Over Feasibility Of A Three-Drug ACS Regimen
While the focus of the Cardiovascular and Renal Drugs Advisory Committee’s meeting was on rivaroxaban’s use in treating acute coronary syndromes, some panelists questioned the wisdom of adding an antithrombin to current dual-antiplatelet therapy standard of care. The lack of data on rivaroxaban’s use with the two newest antiplatelet agents, prasugrel and ticagrelor, also could prove problematic from a labeling perspective due to theoretical concerns about increased bleeding.
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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.
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.
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.