U.S. Food & Drug Administration approves breakthrough drug developed by Ascension Seton researcher
The U.S. Food and Drug Administration (FDA) recently approved a breakthrough antidote drug that could be a potentially life-saving therapy for patients taking blood thinners who experience life-threatening bleeding.
Truman Milling, Jr., MD, research director at Ascension Seton Dell Medical School Stroke Institute and associate professor at Dell Medical School at The University of Texas at Austin, worked alongside Portola Pharmaceuticals, Inc. to develop Andexxa®, the first and only antidote for patients being treated with the blood thinning agents such as rivaroxaban (“Xarelto”) or apixaban (“Eliquis”).
“Before Andexxa®, we had no way to turn off the anticoagulant action of certain blood thinner drugs,” Milling said. “Now, this new antidote will prevent patients taking blood thinners from bleeding out if they are severely injured.”
Factor Xa inhibitors are critical in helping prevent strokes and blood clots in the legs or lungs. They are most commonly taken by patients with an irregular heartbeat, and those who are prone to deep vein thrombosis or pulmonary embolism (blood clots in the lungs).
However, these blood thinners can cause serious bleeding problems if a patient suffers an injury or has a bleeding stomach ulcer, because they reduce the ability of blood to clot.
Andexxa® works by “fooling” Factor Xa inhibitors into binding to it, helping the blood coagulate again if a patient on blood thinners experiences serious bleeding.
Dell Ascension Seton Medical Center at The University of Texas at Austin, the region’s only Level I Trauma Center for adults, and Ascension Seton Medical Center Austin are the only care sites in Texas to offer Andexxa® during the trial phase. The drug can be transferred to other facilities in and outside of Austin as needed. Other trial sites across the U.S. and Europe also offer the drug.
“The transformative clinical and academic partnership between Ascension Seton and UT’s Dell Medical School helped pave the way to research which led to the development of Andexxa®,” Milling said. “Early access to this life-saving drug helps establish Austin as a leader for the future of medicine, and its broader commercial launch is anticipated in early 2019.”