FDA Approves Apixaban, Positive Results in AVF, and More: Vascular News in Review

It’s been a busy couple of weeks for news in the world of vascular medicine. First, there was big news regarding the drug Eliquis (apixaban) from Bristol-Myers Squibb Company and Pfizer, Inc. The U.S. Food and Drug Administration approved apixaban to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis is expected to be widely available in the U.S. by the end of January 2013. In late December, just prior to the announcement of the FDA approval, the Japanese Ministry of Health, Labor and Welfare approved apixaban for the same purpose.

Also, the FDA granted fast track designation to XBiotech for the MABp1 compound, a treatment to reduce the need for reintervention after superficial femoral artery (SFA) revascularization. Results from a Phase II trial showed prolonged patency of the SFA and reduction in major adverse cardiovascular events, indicating both a local treatment effect as well as impact on underlying vascular disease.

Minneapolis-based developer of chronic swelling and vascular disease therapies Tactile Systems Technology, Inc. added veterans from the vascular medicine field to its advisory board, including Thomas F. O’Donnell Jr., MD, Anthony J. Comerota, MD, and Alan T. Hirsch, MD. Drs. O’Donnell and Comerota are contributors to Vascular Disease Management (read a recent interview with Dr. Comerota on treating DVT during pregnancy).

Lastly, biopharmaceutical company Proteon Therapeutics also announced positive results of a Phase II trial of PRT-201, which demonstrated that in patients with chronic kidney disease undergoing surgical placement of an arteriovenous fistula, treatment prolonged primary unassisted patency and improved the rate of AVF maturation.

“AVF patency loss and non-maturation are significant problems, necessitating multiple endovascular (angioplasty) and surgical procedures to restore or maintain blood flow and resulting in prolonged use of dialysis catheters, which have a very high rate of infection. This results in poorer outcomes and significantly increases morbidity and cost,” said Prabir Roy-Chaudhury, MD, PhD, Professor of Medicine at the University of Cincinnati, Academic Health Center, Cincinnati, Ohio, in the news release. He added that the Phase II trial results are encouraging.

Visit the Vascular Disease Management Vascular Newswire for more.


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