Is Apixaban the Next New Anticoagulant?


ApixabanApixaban, CAS number 503612-47-3, is showing itself to be a viable option for patients with atrial fibrillation who are in need of an anticoagulant. In two studies, ARISTOTLE and AVERROES, which included over 24,000 patients, Apixaban (Eliquis) showed statistically significant superiority to Warfarin.  A 21%  lower stroke risk for patients with atrial fibrillation was an encouraging finding from the ARISTOTLE/AVERROES studies. In addition, there was  a 31%  lowered risk of complications from bleeding in patients studied. These combined studies offered exceptional results as to the potential use of Apixaban in stroke prevention, which is a common concern for patients with atrial fibrillation.

A joint venture by Pfizer and Bristol-Myers Squibb, Apixaban is an anticoagulant that is a direct factor Xa inhibitor, or a Vitamin K antagonist.  The typical dose for patients in the studies was five milligrams, given orally, twice daily. The potential concern over medication adherence due to multiple daily doses was not a significant issue in this study, as many patients with atrial fibrillation are used to taking medication several times daily already.

Apixaban is a drug that has been in testing for several years. Earlier studies conducted, such as a 2007 trial, are now in Phase III. These studies focused on combining related competing compounds, such as rivaroxaban, in the prevention of venous thromboembolism. In this study Apixaban showed equivalency when compared to Enoxaparin as an Antithrombotic drug for patients who had undergone a knee replacement surgery. LGM Pharma supplies Apixaban for R&D purposes, and offers assistance to clients through all stages of research.

As generic Warfarin is currently widely available, Apixaban will need to continue to prove both safety and efficacy in further studies to compete in the drug marketplace. A New Drug Application (NDA) for ELIQUIS® (apixaban) was submitted and a decision is expected from the FDA by March 28, 2012.

 

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