J&J Asks US to Approve Third Use for Xarelto
Johnson & Johnson’s drug making unit Janssen asked the U.S. Food and Drug Administration on Thursday to approve its Xarelto anticlotting pill for a third purpose – fighting acute coronary syndrome.
ACS occurs when a blood clot blocks a coronary artery, reducing blood supply to the heart.
Janssen Research & Development’s move is officially termed a New Drug Application. The development comes after results of a clinical trial were released in November showing the pill reduced the risk of death from heart conditions in patients with ACS which include cardiovascular causes, myocardial infarction or stroke.
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 the treatment of irregular heartbeat called atrial fibrillation. It was initially approved in July for preventing blood clots in patients undergoing hip or knee replacement surgery.