February 28th, 2012
FDA Grants Priority Review to Rivaroxaban (Xarelto) for ACS Patients
The FDA has granted a priority review for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) in combination with standard therapy to reduce the risk for cardiovascular events in acute coronary syndrome (ACS) patients. The news was announced by Bayer and Johnson & Johnson. The FDA will now be required to respond within 6 months, instead of 10 months, to the December 29 submission of the sNDA.
The application is based on the results of the ATLAS ACS 2-TIMI 51 study — the first trial to show a benefit with an anticoagulant in ACS. Previous trials testing anticoagulants in the setting of ACS had all failed. One key difference highlighted by many experts was the low doses of rivaroxaban used in the trial. The addition of 2.5 mg bid of rivaroxaban to standard therapy (versus standard therapy alone) resulted in a significant reduction in the combined rate of cardiovascular death, MI, or stroke, as well as significant reductions in death from cardiovascular causes (2.7% vs. 4.1%, p=0.002) and all-cause mortality (2.9% vs. 4.5%, p=0.002). The last two benefits were not found with the higher dose of rivaroxaban (5 mg bid) studied in the trial. Rivaroxaban also caused significant increases in bleeding complications, but not fatal bleeding.
Priority reviews are granted to treatments that offer an advance in care or that provide a treatment where no adequate therapy exists, the companies said.