Surprise to many people today: An FDA staff report released today (Sept 6th, 2011) states that FDA reviewers recommend against the approval of rivaroxaban (Xarelto) for the atrial fibrillation indication. A detailed discussion with reasons for the recommendation can be found here. The main reason: It has not been shown that rivaroxaban is as effective as well-managed warfarin. Even though the huge atrial fibrillation trial showed non-inferiority of rivaroxaban compared to warfarin, the warfarin arm of the study had suboptimal time in therapeutic range (TTR) of INRs (ref 1). Next steps: (a) An advisory panel to the FDA of outside authorities will meet Sept. 8, 2011, to discuss rivaroxaban for use in atrial fibrillation; (b) The FDA is expected to make a final and formal decision about approval in the next 3 months.
Relevance of these news for DVT and PE
The pivotal DVT/PE study (ref 2; discussed on Clot Connect here) has not yet been reviewed by the FDA, so it is not known whether Rivaroxaban will get approval for the DVT/PE indication or not. A summary of the 4 big new oral anticoagulants in development and their present FDA approval status can be found here.
References
- Patel MR et al. N Engl J Med. Aug 10, 2011 (ePub ahead of print)
- EINSTEIN investigators. Oral Rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499-2510.
ADDENDUM
On Nov 4th, 2011 the FDA approved Rivaroxaban for the atrial fibrillation indication – details here.
Disclosures: I have consulted for OthoMcNeil and Bayer, the companies developing Xarelto.
Last updated: Nov 4th, 2011
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One response to “Rivaroxaban (Xarelto): FDA Advisory Board Recommends Against Approval for Atrial Fibrillation”
[…] The external advisory board to the FDA recommended today to approve Rivaroxaban (Xarelto) for the stroke prevention in atrial fibriallation. More details about the vote can be found here. Today’s recommendation is contrary to the one given by an internal FDA review committee which had recommended 2 days ago to NOT approve the drug for atrial fibrillation (discussed on Clot Connect here). […]