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Is Approval of Apixaban in the U.S. Near?

(Pub. 19th August, 2012)

Exciting news emerged at the 2012 International Stroke Conference, which was held in New Orleans in February of 2012. Apixaban was praised by the pharmaceutical community as being a novel and impressive medication to treat patients with atrial fibrillation, who are in need of an anticoagulant. Positive results were touted from two studies of Apixaban, which were conducted with the support from Bristol-Myers Squibb and Pfizer. These studies, coined ARISTOTLE and AVERROES,  included over 24,000 patients combined. In the AVVEROES study of Apixaban, which is also known by the brand name Eliquis,  5,599 patients with atrial fibrillation were studied for one year. The mean age of patients in this study was 70 years of age, and all patients had an increased risk for stroke along with atrial fibrillation, or AF. Participants were randomly assigned to receive a twice-daily dose of apixaban 5 milligrams, or a daily aspirin therapy, ranging from 80 milligrams to 324 milligrams. The mortality rate of patients was higher for the group of participants who received aspirin as compared to those who were dosed with apixaban, specifically 6.5% versus 5.3%.  In addition, the risk of excess bleeding in patients was equal for both aspirin and apixaban.

 As a joint venture by Pfizer and Bristol-Myers Squibb, Apixaban (Eliquis) 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. Thromboembolic diseases are a common cause of mortality and morbidity. Venous thromboembolism, or occurs in 1–2 adults per 1000 in the United States each year. Finding an efficacious and safe treatment for these patients is crucial. With an estimated 2.2% of all strokes are attributable to atrial fibrillation in the U.S. alone, roughly 17,500 of the 795,000 strokes that occur annually are a result of AF. The clear need for medication to combat this life threatening condition worldwide is evident. Treatment with Apixaban offers patients an effectual and tolerable solution.

Already approved in Europe, Apixaban (Eliquis) is awaiting the final FDA approval in the United States. On June 25, 2012 the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ELIQUIS® (apixaban) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. There are no new requests by the FDA for additional studies regarding Eliquis (Apixaban), and both Bristol-Myers Squibb and Pfizer are confident that the approval of this innovative anticoagulant will be completed expeditiously.

 

YES Pharma is proud to be a leading supply source for Apixaban (CAS#: 503612-47-3) to several global pharmaceutical companies and academic research institutes, while recognizing that we play a significant part in for the prevention of venous thromboembolism and other thromboembolic diseases. The Apixaban that YES Pharma supplies is intended for laboratory R&D use only.

References:

Posted: 07/10/2012; Am J Health Syst Pharm. 2012;69(13):1113-1126. © 2012 American Society of Health-System Pharmacists
Diener CH. Abstract #3776. Presented at: the American Stroke Association’s International Stroke Conference 2012; Feb. 1-3, 2012; New Orleans.
Bristol-Myers Squibb and Pfizer Receive Complete Response Letter from U.S. Food and Drug Administration for ELIQUIS® (apixaban)Category: R&D News June 25, 2012.

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