Bristol-Myers and Pfizer’s Eliquis demonstrates efficacy in Phase III study

30th June 2013 (Last Updated June 30th, 2013 18:30)

Bristol-Myers Squibb Company and Pfizer have announced that Eliquis (apixaban), an oral direct Factor Xa inhibitor, achieved primary efficacy endpoint in a Phase III AMPLIFY study in patients to treat acute venous thromboembolism (VTE).

DVT

Bristol-Myers Squibb Company and Pfizer have announced that Eliquis (apixaban), an oral direct Factor Xa inhibitor, achieved primary efficacy endpoint in a Phase III AMPLIFY study in patients to treat acute venous thromboembolism (VTE).

Acting as a single-agent, Eliquis demonstrated significantly lower rates of major bleeding in patients against current standard of care to treat VTE.

Eliquis was non-inferior in reducing the composite endpoint of recurrent symptomatic VTE or VTE-related death to current standard of care for treatment of both symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) conditions.

Patients on Eliquis demonstrated 69% relative risk reduction (RRR) for major bleeding compared to current standard of care.

Professor of internal medicine, University of Perugia, Italy and leader of the study Dr Giancarlo Agnelli said that the results complement the previously published results for the AMPLIFY-EXT study.

"Together these studies represent exciting data in the field of VTE treatment and indicate that apixaban may offer an important potential alternative in both acute and extended anticoagulation therapy for VTE patients," Agnelli added.

Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapy (AMPLIFY) study had included 5,395 patients with confirmed symptomatic DVT or PE requiring treatment for six months.

In the randomised, double-blind, multicentre trial, the primary efficacy outcome occurred in 59 patients in the Eliquis group (2.3%) and 71 patients (2.7%) receiving current standard of care.

The primary safety endpoint of superiority for major bleeding was achieved in 0.6% of patients administered with Eliquis and 1.8% of those received current standard of care.


Image: Venograms of DVT. Photo: Hellerhoff.