Healthcare Industry News:  metabolic disease 

Biopharmaceuticals Cardiology FDA

 News Release - May 9, 2012

Janssen Research & Development Submits Supplemental New Drug Application to U.S. FDA for XARELTO(R) (rivaroxaban) to Reduce the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome

RARITAN, N.J., May 9, 2012 -- (Healthcare Sales & Marketing Network) -- Janssen Research & Development, LLC (Janssen) announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of XARELTOŽ (rivaroxaban), an oral anticoagulant, to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome (ACS). XARELTOŽ currently is under review with the U.S. FDA to reduce the risk of secondary cardiovascular events in patients with ACS. XARELTOŽ already is approved in the U.S. to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery, and 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.

The filing is supported by data from the 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) trial, which was presented in November 2011 at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine (10.1056/NEJMoa1112277).

In the trial, the 2.5 mg twice-daily (BID) dose of rivaroxaban was associated with a 35% Relative Risk Reduction in the rate of stent thrombosis compared to placebo [2.2% vs. 2.9% (Hazard Ratio: 0.65; Confidence Interval: 0.45-0.94)]*. Rates of TIMI (Thrombolysis In Myocardial Infarction) major bleeding events not associated with coronary artery bypass graft surgery were low overall in the trial, but rivaroxaban was associated with higher rates of these bleeds in the 2.5 mg BID dose compared to placebo [1.8% vs. 0.6% (Hazard Ratio: 3.46; Confidence Interval: 2.08-5.77)]. Importantly, these differences were not associated with an excess risk of fatal bleeding. Additional data on stent thrombosis, from the ATLAS ACS 2 TIMI 51 trial, will be presented later this year.

Coronary stents are implanted in more than 1.5 million patients each year. Stent thrombosis is an uncommon, but catastrophic complication that may occur after a stent has been inserted into a patient's coronary artery. Stent thrombosis can result in a heart attack or even death.

About XARELTOŽ (rivaroxaban)

XARELTOŽ belongs to a group of medicines called anticoagulants, and works by blocking the blood clotting Factor Xa, thereby reducing the tendency to form clots. In the U.S., XARELTOŽ is a prescription medication used to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery, and 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. There is limited information on how XARELTOŽ compares to a medicine called 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.

The extensive program of clinical trials evaluating rivaroxaban makes the compound the most studied oral, Factor Xa inhibitor in the world today. Rivaroxaban is being developed jointly by Janssen Research & Development, LLC and Bayer HealthCare. U.S. marketing rights for XARELTOŽ are held by Janssen Pharmaceuticals, Inc.

About Janssen Research & Development, LLC

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc., are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssenrnd.com for more information.

*Based on modified ITT population. Mega JL, Braunwald E, Wiviott SD, et al. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2011;366(1):9-19.


Source: Janssen Research & Development

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