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Gibson et al make strides with new drug application

March 1, 2012

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 of 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 upon the results of the ATLAS ACS 2-TIMI 51 study, which was the first trial to show a benefit in ACS with an anticoagulant. 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 resulted in a significant reduction in the combined rate of cardiovascular death, MI, or stroke, as well as a significant reduction 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) also 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 company said.

To read more, click here (CardioBrief).

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