Janssen files Xarelto sNDA for ACS; FDA to review Amgen's Xgeva for CRPC

US health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen Research & Development, has submitted a supplemental New Drug Application to the US Food and Drug Administration 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), under a commercialization deal with Germany’s Bayer (BAY: DE).

The filing is supported by data from the pivotal Phase III ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome) trial, which was presented in November at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine.

ACS is a complication of coronary heart disease, which is the leading cause of death in the USA and also one of the most prevalent non-communicable diseases in the world.. Each year, an estimated 1.2 million patients in the U.S. are discharged from the hospital with a primary or secondary diagnosis of ACS. Xarelto was approved two months ago for use in patients who have an irregular heartbeat called atrial fibrillation not caused by a heart valve problem and was first approved in July, for preventing blood clots in patients undergoing hip or knee replacement surgery.