looks like one less competitor for MNTA ...
New Data Presented On Phase 3 Trial Of ELIQUIS(R) (apixaban) In The Prevention Of Venous Thromboembolism In Patients With Acute Medical Illness
PRINCETON, N.J. & NEW YORK (Business Wire) -- Bristol-Myers
Squibb Company (NYSE: BMY) and Pfizer
Inc. (NYSE: PFE) today announced the results of the Phase 3 ADOPT
(Apixaban Dosing to Optimize Protection from Thrombosis) trial, which
evaluated apixaban versus enoxaparin in acutely ill medical patients,
did not meet the primary efficacy outcome of superiority to enoxaparin
for the endpoint of venous thromboembolism (VTE) and VTE-related death
at day 30. The apixaban arm had a 13 percent lower rate of events than
enoxaparin followed by placebo, which favored apixaban but was not
statistically significant and thus no clinically directive conclusion
can be drawn. The key safety outcome of major bleeding was low in both
groups but occurred in more patients treated with apixaban than with
enoxaparin (0.47 percent of patients in the apixaban group and 0.19
percent of patients in the enoxaparin group (P=0.04)). The study results
were presented during a late-breaking session at the annual American
Heart Association (AHA) Scientific Sessions in Orlando, FL, and
published in the New England Journal of Medicine.
"Solving the problem of VTE post-hospitalization remains a critical
unmet need in preventing medically ill patients from developing deep
vein thrombosis and pulmonary embolism," said Dr. Samuel Z. Goldhaber,
senior cardiologist at Brigham and Women's Hospital, and Professor of
Medicine, Harvard Medical School, Boston, MA. "ADOPT provides important
insights for clinical trialists designing studies of extended duration
VTE prophylaxis among medically ill hospitalized patients."
ELIQUIS (R) (apixaban), a new oral direct Factor Xa inhibitor,
is part of a class of agents being studied for their potential to
prevent and treat blood clots in multiple indications. ELIQUIS is
currently approved in the 27 countries of the European Union (EU) for
the prevention of VTE in adult patients who have undergone elective
total hip or knee replacement surgery.
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