Janssen receives complete response letter from FDA for XARELTO sNDA

Janssen Research & Development, LLC (Janssen) today announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the supplemental New Drug Application (sNDA) for XARELTO^® (rivaroxaban) to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS).

"We remain confident in the results of the ATLAS ACS 2 TIMI 51 trial and are in ongoing discussions with the FDA regarding this sNDA," said Dr. Christopher Nessel, Vice President, Cardiovascular Franchise Medical Leader at Janssen.

This sNDA is based on results from the 15,526-patient pivotal Phase 3 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) clinical trial of XARELTO^® which were presented at the American Heart Association annual Scientific Sessions in November 2011 and simultaneously published by the New England Journal of Medicine.  Data from the ATLAS ACS 2 TIMI 51 trial also support the separate sNDA for XARELTO^® to reduce the risk of cardiovascular events in patients with ACS, for which Janssen received a second complete response letter on March 4, 2013.

Coronary stents are implanted in more than 1.5 million patients each year. Stent thrombosis occurs when blood pools at the site of an implanted stent within a patient's coronary artery. Stent thrombosis is an uncommon, but serious complication that can result in a heart attack or even death.

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 non-communicable 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.

XARELTO^® is the most prescribed novel oral anticoagulant in the U.S. market today and is approved for six clinical uses in the U.S. It has earned the strongest reimbursement profile among novel anticoagulants, with 85 percent of patients on Medicare Part D and 85 percent of commercial patients covered at the lowest branded co-pay. To date, more than 5 million patients have received XARELTO^® worldwide and more than 2 million prescriptions have been written for XARELTO^® in the U.S.