Janssen Answers FDA Query Regarding Wider Use of Xarelto (Rivaroxaban)
Company seeks approval for reduction of secondary coronary events in ACS (Sept. 7)Janssen Research & Development, LLC, based in Raritan, N.J., announced on September 7 that it has submitted a complete response to the FDA for the use of Xarelto (rivaroxaban) to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS). The response includes specific information requested by the FDA in a letter issued to Janssen on June 21.
Janssen also has resubmitted a supplemental New Drug Application (sNDA) for Xarelto to reduce the risk of stent thrombosis in patients with ACS, which the company withdrew on July 9. Data from the pivotal ATLAS ACS 2 TIMI 51 trial support both sNDAs.
Xarelto is approved for three clinical uses in the U.S.: 1) to reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery; 2) to reduce this risk in people who have just had hip replacement surgery; and 3) to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem.
ACS is a complication of coronary heart disease, which is the leading cause of death in the U.S. and one of the most prevalent noncommunicable diseases in the world. ACS occurs when a blood clot blocks a coronary artery, reducing blood supply to the heart. This disruption of blood flow can cause a heart attack or unstable angina, a condition signifying that a heart attack may soon occur. Each year, an estimated 1.2 million patients in the U.S. are discharged from the hospital with a diagnosis of ACS.
Coronary stents are implanted in more than 1.5 million patients each year. Stent thrombosis is uncommon, but may result in a catastrophic complication after a stent has been inserted into a patient’s coronary artery. Stent thrombosis can result in a heart attack or death.
Xarelto is an anticoagulant drug that works by blocking Factor Xa, a blood-clotting factor, thereby reducing the tendency to form clots. Limited information is available on how Xarelto compares with warfarin in reducing the risk of stroke when the blood levels of warfarin are well-controlled. The blood levels of warfarin often vary in patients.
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