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Biopharmaceuticals Cardiology FDA

 News Release - September 8, 2011

FDA Advisory Committee Recommends Approval of Oral Anticoagulant Rivaroxaban for the Prevention of Stroke and Systemic Embolism in Patients with Non-Valvular Atrial Fibrillation

RARITAN, N.J.--(Healthcare Sales & Marketing Network)-- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) announced today that the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended approval of rivaroxaban, a novel, once-daily, oral anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). The committee voted 9-2 in favor of rivaroxaban in patients with AF who are at risk of stroke and systemic embolism.

"We are pleased with the committee’s recommendation and look forward to working with the FDA to help make this important therapy available in the U.S.," said Peter M. DiBattiste, M.D., Global Therapeutic Area Head, Cardiovascular and Metabolism, J&JPRD.

Data presented at today’s advisory committee meeting included results from the pivotal, global, double-blind Phase 3 ROCKET AF (Rivaroxaban Once-daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for the prevention of stroke and Embolism Trial in Atrial Fibrillation) clinical trial, which demonstrated that once-daily rivaroxaban had a 21% relative risk reduction in stroke and non-CNS systemic embolism while on-treatment compared to warfarin, with low and comparable bleeding rates1.

ROCKET AF compared oral, once-daily rivaroxaban with dose-adjusted warfarin in 14,264 patients with non-valvular AF who are at risk for stroke and non-CNS systemic embolism. The study was designed to first demonstrate that rivaroxaban was non-inferior to warfarin (the study’s primary efficacy endpoint). Once non-inferiority was established, data was assessed for superiority with an “on-treatment” population (i.e., patients on study drug and followed for events while on the drug for duration of the trial). The analysis for superiority was pre-specified. An additional confirmatory analysis was also performed in the intention to treat (ITT) population and including data to the end of the study. This group included all randomized patients followed for events, including periods both on and off treatment, until trial completion.

Recommendations from the advisory committee will be considered by the FDA in its review of the New Drug Application for rivaroxaban in this indication that was submitted by J&JPRD on January 5, 2011, but are not bound to directly follow them. If approved by the FDA, Janssen Pharmaceuticals, Inc. will commercialize rivaroxaban in the U.S.

Atrial Fibrillation and Stroke

AF is the most common sustained cardiac rhythm disorder and affects more than 2.3 million people in the U.S. In patients with AF, the heart’s irregular heartbeat makes them vulnerable to the formation of a blood clot in the atria, which can travel to the brain, potentially resulting in a stroke. Strokes can lead to physical and behavioral impairments, or even death. People living with AF are at a five-fold increased risk for stroke compared with the general population. Worldwide, stroke is the second leading cause of death above the age of 60 years, and is the fifth leading cause in people aged 15 to 59 years, responsible for 5 million deaths each year. Stroke leaves an additional five million people permanently disabled annually.

About Rivaroxaban

XARELTO® (rivaroxaban tablets), was approved by the FDA on July 1, 2011 for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery. It works by blocking the blood clotting Factor Xa and thereby reduces the tendency of the blood to form clots.

Additionally, XARELTO® is being investigated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. The extensive program of clinical trials evaluating rivaroxaban makes the compound the most studied oral, Factor Xa inhibitor in the world today. By the time of its completion, more than 65,000 patients will have participated in the rivaroxaban clinical development program. Rivaroxaban is being developed jointly by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Bayer HealthCare.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a wholly-owned subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is actively involved in drug discovery and development within a variety of therapeutic areas, including Cardiovascular and Metabolism, Central Nervous System, Immunology, Oncology and Virology, to address unmet medical needs worldwide. More information can be found at http://www.jnjpharmarnd.com.

Janssen Pharmaceuticals, Inc.

As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Janssen Pharmaceuticals, Inc., is dedicated to addressing and solving some of the most important unmet medical needs in pain management, infectious diseases and cardiovascular and metabolic diseases. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to individuals with serious conditions, and to physicians throughout the world.

For more information on Janssen Pharmaceuticals, Inc., visit us at www.janssenpharmaceuticalsinc.com or follow us on Twitter at www.twitter.com/JanssenUS.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from J&JPRD and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither J&JPRD nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

Please see full Product Information at www.XARELTOhcp.com

1 Patel PR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011


Source: Johnson & Johnson

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