The US Food and Drug Administration’s (FDA’s) Cardiovascular and Renal Drugs Advisory Committee has voted against expanding the use of oral anticoagulant Xarelto (rivaroxaban) 2.5mg 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 panel reached the decision following the review of the results of a global Phase III ATLAS ACS 2-TIMI 51 trial, which involved over 15,500 patients in the prevention of thrombotic cardiovascular events such as heart attack, stroke or cardiovascular death in ACS patients.
Bayer HealthCare discovered rivaroxaban and is currently jointly developing it with Janssen Research & Development.
Outside the US, Xarelto is marketed by Bayer HealthCare, while in the US by Janssen Pharmaceuticals.
The FDA will consider recommendations from the advisory committee in its review of the supplemental new drug application (sNDA) for rivaroxaban in this indication, although it is not bound to follow them.
Bayer HealthCare executive committee member 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 finalise their review."
The Phase III 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.
The European Commission approved Xarelto in May 2013 for the prevention of atherothrombotic events after an ACS in adult patients with elevated cardiac biomarkers at a dose of 2.5mg twice daily (BID) co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine.
According to the company, Xarelto is approved for five indications across seven distinct areas of use.
Image: Bayer HealthCare’s research site at Berlin, Germany. Photo courtesy of Bayer AG.