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, NJ (September 8, 2011) — 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 rates.
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.
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.
(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.)
Important Safety Information
WHAT IS XARELTO®?
XARELTO®(rivaroxaban tablets) is a prescription medicine used to help prevent blood clots from forming in patients after hip or knee replacement surgery.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?
- You should take XARELTO® exactly as directed by your doctor
- Do not skip a dose or stop taking XARELTO® unless you are advised to do so by your doctor. Stopping may increase your risk of a blood clot
- If a dose is missed, take XARELTO as soon as possible and continue on the following day, taking XARELTO® as directed by your doctor. Do not take two doses at the same time
- XARELTO® can cause bleeding, which can sometimes be serious, even life-threatening. You may find you bruise or bleed more easily while you take it. It might take longer than usual to stop bleeding
- Alert your doctor right away if you develop any:
- Tingling, numbness or muscle weakness, especially in your legs. This is particularly important if you had a procedure called spinal or epidural puncture as part of your anesthesia for your hip or knee replacement surgery.
- Unusual bleeding or bruising (bruises that develop without an injury or grow in size)
- New bleeding (for example, nose bleeds, bleeding gums, red urine, bright red blood in your stool, coughing up or vomiting blood)
- Bleeding that is heavier than usual (for example, from cuts or menstruation)
- Dizziness, weakness, or tiredness, all of which could indicate a loss of blood
- Pain, swelling, or new fluid leakage in or around the surgical incision
WHO SHOULD NOT TAKE XARELTO®?
Tell your doctor if you have:
- Unusual bleeding
- Ever had an allergic-type (hypersensitivity) reaction to XARELTO®
WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO®?
- Tell your doctor or dentist about all the medicines you take.
- This includes XARELTO®, any other prescription and nonprescription medicines, over-the-counter medications, and herbal supplements.
- Tell your doctor if you:
- Have a bleeding disorder or have problems with unusual bleeding
- Have any problems with your kidneys or liver
- Are pregnant or planning to become pregnant
- Are breast-feeding or are planning to breast-feed
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
- XARELTO® may increase your chance of bleeding. This bleeding can sometimes be serious (and even life-threatening)
- In studies side effects with XARELTO® included fluid leakage from a wound, itching, pain in arms or legs, blisters, fainting, and muscle spasm.
- Discuss any side effects with your doctor. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (526-7736)
This is a summary of important information about XARELTO®. If you would like more information, talk with your doctor.
For more information on rivaroxaban, please contact:
Tel: (908) 927-2953
Mobile: (917) 697-2318
Tel: (908) 927-2416
Mobile: (973) 476-7144
Johnson & Johnson
Tel: (732) 524-6491
Johnson & Johnson
Tel: (732) 524-2524
 Patel PR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011