28 May 2012 | News | By BioSpectrum Bureau
FDA committee votes against Xarelto
US FDA's Cardiovascular and Renal Drugs Advisory Committee voted against approval of Xarelto (rivaroxaban) to reduce the risk of secondary cardiovascular events in patients with ACS
Singapore: US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted against the approval of Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS) in combination with standard antiplatelet therapy by Janssen Research & Development.
"We appreciate the thoroughness of the committee's review, and will ensure the questions raised today are addressed with the FDA," said Dr Paul Burton, vice president, Cardiovascular Franchise Medical Leader at Janssen.
Xarelto is approved in the US to reduce the risk of blood clots in the legs and lungs of people who have had knee or hip replacement surgery, and to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem.