Phase III success for apixaban
pharmafile | March 5, 2010 | News story | Research and Development | BMS, Pfizer, VTE, apixaban
Pfizer and Bristol-Myers Squibb’s apixaban has shown promising results in a late-stage head-to-head trial with Sanofi-Aventis’ Lovenox.
The oral anti-coagulant performed better than the injectable Lovenox (enoxaparin) in reducing incident of venous thromboembolism (VTE) in patients undergoing elective knee replacement surgery.
The results will be heartening for development and marketing partners Pfizer and BMS because Lovenox is the current market leader in the therapy area.
The findings were published in The Lancet this week and came from the Advance-2 study, a randomised, double-blind, multicenter, head-to-head trial that involved 3,200 patients from 27 countries.
It was designed to evaluate the efficacy and safety of oral, twice daily apixaban 2.5mg compared with subcutaneous enoxaparin 40mg once-daily, over a 10-to-14 day treatment period for reducing the risk of VTE in patients undergoing elective total knee replacement surgery.
When apixaban was compared with enoxaparin, the primary efficacy endpoint occurred in 15.1% of patients in the apixaban group and 24.4% of patients in the enoxaparin group, demonstrating a statistically significant relative risk reduction for apixaban of 38%.
The primary safety measure of major bleeding did not reach statistical significance, occurring in 0.6% of apixaban patients and in 0.9% of enoxaparin patients.
VTE encompasses two serious conditions, deep vein thrombosis and pulmonary embolism, and occurs in 40-60% of patients undergoing orthopaedic surgery who do not receive preventive care.
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