J&J To Persevere In ACS After Another “Complete Response” For Xarelto
This article was originally published in The Pink Sheet Daily
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.
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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.
With bigger clinical trials come potentially bigger problems. That, at least, is what sponsors of 15,000-plus trials in cardiovascular medicine are finding out. J&J/Bayer’s experience in late May with Xarelto for acute coronary syndrome is a case in point—and it also provides timely context for the surprising setback for another CV project, Pfizer/BMS' Eliquis.