Xarelto Label Expansion Plans Slowed By FDA “Complete Response” On ACS Claim
This article was originally published in The Pink Sheet Daily
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.
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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.
J&J/Bayer’s Xarelto currently has the broadest label among new anticoagulants, with a new indication in the U.S. for venous thromboembolism. But Bristol/Pfizer’s Eliquis is also being positioned for broader use in VTE, with positive data reported at the American Society of Hematology meeting in December.