September 8th, 2011
FDA Advisory Panel Gives Yellow Light to Rivaroxaban
The FDA Cardiovascular and Renal Drugs Advisory Committee voted 9-2 (with 1 abstention) in support of rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in patients with atrial fibrillation, but the vote did not represent a ringing endorsement of the drug. The committee wrestled throughout the day with the numerous concerns raised by FDA reviewers, who had recommended that the drug be rejected. The committee left three key issues for the FDA to resolve if it approves the drug:
- Although rivaroxaban was noninferior to warfarin in the pivotal ROCKET trial, warfarin was not used as skillfully in ROCKET as in RE-LY and other recent trials, thereby making it difficult to assess the true efficacy of rivaroxaban.
- Because of a high number of events observed in patients when they discontinued use of rivaroxaban, there is no firm guidance for how to transition patients to warfarin or other drugs when rivaroxaban is discontinued.
- The optimal dose of rivaroxaban is still unclear. Many on the committee thought rivaroxaban might perform better as a twice-a-day drug.