XARELTO Application Submitted to U.S. FDA
Janssen Research & Development, LLC has submitted a supplemental New Drug Application to the FDA seeking approval for the use of anticoagulant XARELTO.
Janssen Research & Development, LLC announced Thursday that it has submitted a supplemental New Drug Application (sNDA) to the U.S. FDA seeking approval for the use of XARELTO (rivaroxaban), an oral anticoagulant, to reduce the risk of (thrombotic) cardiovascular events in patients with Acute Coronary Syndrome (ACS).
ACS is a complication of coronary heart disease, which is the leading cause of death in the U.S. and also one of the most prevalent non-communicable diseases in the world.
The filing is supported by data from the pivotal Phase 3 ATLAS ACS 2 TIMI 51 trial, which was presented in November at the American Heart Association Scientific Sessions.
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