FDA Questions Evidence For Janssen’s Xarelto In Acute Coronary Syndrome
This article was originally published in The Pink Sheet Daily
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.
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J&J says it remains confident about getting expanded approval for Xarelto after receiving a “complete response” letter from FDA for reducing risk of stent thrombosis in patients with acute coronary syndrome.
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.
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.