17.01.2014 07:29:56
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Bayer Says FDA Panel Votes Against Wider Use Of Blood Thinner Xarelto
(RTTNews) - Bayer HealthCare, a unit of Bayer AG (BAYZF.PK, BAYRY.PK, BYR.L), Thursday said the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted against the approval of oral blood thinner Xarelto 2.5 mg twice daily in combination with standard antiplatelet therapy to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome.
Thrombotic cardiovascular events include heart attack, stroke or cardio-vascular death.
Recommendations from the Advisory Committee will now be considered by the FDA in its review of the supplemental New Drug Application for rivaroxaban in this indication.
Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development, said, "We will work together with our cooperation partner Janssen Research & Development, LLC, so that the FDA can finalize their review."
Data presented at the Advisory Committee meeting included results from the pivotal, global Phase III ATLAS ACS 2-TIMI 51 study involving over 15,500 patients in the prevention of thrombotic cardiovascular events in patients with Acute Coronary Syndrome.
The study compared oral rivaroxaban dosed twice daily in addition to standard antiplatelet therapy, which was low-dose aspirin with or without a thienopyridine such as clopidogrel, with standard antiplatelet therapy alone.
The results of the study were presented at the American Heart Association Annual Scientific Sessions in November 2011 and published simultaneously by the New England Journal of Medicine.
Xarelto is marketed outside the U.S. by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc., a Johnson & Johnson (JNJ) company.
Bayer fell 0.4 percent on Thursday to close at 101.25 euros.
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