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VTE prevention drug fails Phase 3 trial

 Eliquis (apixaban), an oral drug from Pfizer and Bristol-Myers Squibb for the prevention of venous thromboembolism (VTE) in acutely ill patients, has failed to meet the required endpoint in a Phase 3 clinical study.

In the ADOPT trial, Eliquis did not meet the primary efficacy outcome of superiority to enoxaparin in preventing VTE and VTE-related death.

Eliquis performed 13% better than enoxaparin in preventing VTE events, which was not statistically significant, over 30 days.

Major bleeding, a key safety outcome, occurred more often with Eliquis than with enoxaparin but had a low frequency (0.47% and 0.19% respectively) in both groups.

VTE encompasses two dangerous events: pulmonary embolism and deep vein thrombosis (which can lead to pulmonary embolism).

Eliquis, an anticoagulant, is a direct factor Xa inhibitor and is currently approved in the EU for the prevention of VTE in adult patients who have undergone hip or knee replacement surgery.

ADOPT (Apixaban Dosing to Optimise Protection from Thrombosis) was a Phase 3, international, multi-centre, randomised, double-blind, controlled study comparing apixaban with enoxaparin in acutely ill patients.

Over 30 days, VTE events occurred in 2.71% of patients in the Eliquis group and 3.06% of patients in the enoxaparin group. Overall, the outcomes for both patient groups were similar.

Dr. Samuel Z. Goldhaber, senior cardiologist at Brigham and Women’s Hospital, commented: “ADOPT provides important insights for clinical trialists designing studies of extended duration VTE prophylaxis among medically ill hospitalised patients.

“Solving the problem of VTE post-hospitalisation remains a critical unmet need in preventing medically ill patients from developing deep vein thrombosis and pulmonary embolism.”

Eliquis has been co-developed by Pfizer and Bristol-Myers Squibb since 2007, following its discovery by BMS.

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