Bayer's Xarelto wins out in study
Germany's Bayer HealthCare reported that its Xarelto (rivaroxaban) anticoagulant showed superior efficacy compared to enoxaparin, the active ingredient in Sanofi-Aventis' Clexane-Lovenox, in the late-stage RECORD4 trial, at the annual meeting of the European Federation of National Associations of Orthopedics & Traumatology in Nice, France.
The Phase III clinical study compared Bayer's once-daily oral drug candidate to the twice-daily, injectable, treatment standard for venous blood clots in 3,148 patients following total knee replacement surgery. Bayer's direct Factor Xa inhibitor showed a statistically-significant (31%) reduction of venous thromboembolism when compared with enoxaparin. It also demonstrated a low and not statistically-different rate of major bleeding by comparison, according to the firm.
This is the fourth successful clinical trial for Bayer's candidate and the firm plans to file for US approval in the next few months. The drug has already been submitted in 10 countries, including Canada and China.
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