Bayer HealthCare has failed to win the backing of the US FDA's Cardiovascular and Renal Drugs Advisory Committee to expand the use of its oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice daily (BID) in combination with standard antiplatelet therapy to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS).
The FDA will consider recommendations from the advisory panel in its review of the supplemental new drug application (sNDA) for rivaroxaban in this indication, although the FDA is not bound to follow them.
Bayer HealthCare member of the executive committee and head of global development Kemal Malik said, "We will work together with our cooperation partner Janssen Research & Development, LLC, so that the FDA can finalize their review."
Discovered by Bayer HealthCare, rivaroxaban is jointly developed with Janssen Research & Development.
Outside the US, Xarelto is marketed by Bayer HealthCare and in the US by Janssen Pharmaceuticals, a Johnson & Johnson Company.
The data submitted to the advisory committee included results from a global Phase III ATLAS ACS 2-TIMI 51 trial, which involved more than 15,500 patients in the prevention of thrombotic cardiovascular events (defined as heart attack, stroke or cardiovascular death) in ACS patients.
The trial compared oral rivaroxaban dosed twice daily in addition to standard antiplatelet therapy - low-dose aspirin with or without a thienopyridine such as clopidogrel - with standard antiplatelet therapy alone.
Image: Bayer HealthCare's research site at Berlin, Germany. Photo: courtesy of Bayer AG.
