Results from a Phase III study showed that patients who took Johnson & Johnson's and Bayer's anticoagulant Xarelto (rivaroxaban) following total knee replacement surgery were less likely to develop venous thromboembolisms (VTE) than patients who were given sanofi-aventis' Lovenox, Bayer announced. The data were presented at the European Federation of National Associations of Orthopaedics & Traumatology meeting.
The RECORD4 study involved 3148 patients who received either oral Xarelto once daily or a twice-daily injection of Lovenox for 10 to 14 days after total knee replacement surgery. The data showed that 6.9 percent of patients in the Xarelto group experienced VTE, compared with 10.1 percent of those administered Lovenox. Bayer indicated that the results correspond to a 31-percent relative risk reduction for Xarelto.
Findings from three previous studies have shown that Xarelto lowers VTE event rates compared to Lovenox following orthopaedic surgery. Ulrich Huwald, an analyst at MM Warburg, commented that the latest findings "[confirm] the blockbuster potential of the drug," adding that "the outcome is better than the non-inferiority that people are expecting." Deutsche Bank analyst Tao Levy stated that the "results are significant, as most patients and clinicians would opt for an oral medication over an injectable." The analyst also suggested that the drug will be "one of the key products that will help Johnson & Johnson fight off generic competition over the near term."
Last year, Bayer submitted Xarelto to EU regulators. The company noted that it expects to file for FDA approval in mid-2008. If approved, the treatment will be marketed by Bayer in the EU and by Johnson & Johnson in the US.
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