Bristol-Myers Squibb, Pfizer Report 4-Factor PCCs Reverse Anticoagulant Effect Of Eliquis

Bristol-Myers Squibb (BMS) and Pfizer report that 4-factor prothrombin complex concentrates (PCCs) reverse the anticoagulant effect of Eliquis (apixaban). The companies announced the study results in a press release, stating that it was reporting the data at the annual meeting of the American Society of Hematology (ASH) in San Francisco, CA. The study evaluated Sanquin’s Cofact and CSL Bering’s Beriplex P/N in reversing the pharmacodynamic effects of Eliquis. Douglas Manion, MD, head of specialty development at BMS, said, “Throughout our collaboration with Pfizer, the alliance has been dedicated to further investigating the use and application of Eliquis. We are pleased with the positive results of this study and look forward to further exploration of prothrombin complex concentrates.”

Eliquis

Eliquis is an oral agent that inhibits Factor Xa, decreasing thrombin generation and blood clot formation. The Food and Drug Administration (FDA) approved Eliquis in 2012 to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. In March 2014, the federal agency approved it to reduce the risk of blood clots following hip or knee replacement therapy. In August 2014, the FDA approved it for the treatment of deep vein thrombosis and pulmonary embolism. Dr. Manion stated that the agent offers advantages in oral dosing and no routine coagulation testing.

Eliquis PCC Study

Dr. Manion explained his company’s interest in reversing Eliquis’ action, stating that Eliquis has no antidote. His remarks came in reaction to results that showed Portola’s andexanet alfa reverses the anticoagulation effects of Eliquis. In the study, andexanet alfa achieved a 94 complete reversal rate in healthy volunteers ages 50-75. In the study that BMS and Pfizer are reporting, investigators evaluated the use of PCCs to reverse the anticoagulant effect of Eliquis. The study used Cofact and Beriplex P/N, commonly used to stop severe bleeding in patients taking vitamin K antagonists like warfarin.

The placebo-controlled study evaluated 15 healthy, adult subjects who received Eliquis 10 mg twice a day. On day four, subjects received Cofact, Beriplex P/N, or a saline solution. The Cofact infusion achieved a significant reduction of the Eliquis effect. The Beriplex P/N infusion achieved a reduction but not a statistically significant reduction. Among the treatment arms, no patients suffered a serious adverse event.

Pfizer and BMS state that the data demonstrated efficacy of Cofact and Beriplex P/N in reversing the effects of Eliquis and provides further evidence for evaluating PCCs in Eliquis patients who require a reversal of the anticoagulant effect.