U.S. FDA Grants Priority Review for XARELTO@ (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
Janssen Research & Development, LLC (JRD) announced today that the U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for XARELTO@ (rivaroxaban), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS).
The FDA grants Priority Review to medicines that offer advances in care or that provide a treatment where no adequate therapy exists.
Under the Prescription Drug User Fee Act (PDUFA), FDA will complete its review within six months from the receipt of the sNDA submission, rather than the standard 10 month review cycle.
The submission was based on results 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 that were presented in November 2011 at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine (10.1056/NEJMoa1112277).
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 primary or secondary diagnosis of ACS.
About XARELTO @ (rivaroxaban) XARELTO@ 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., XARELTO@ is indicated to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery and to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. There is limited information on how XARELTO@ 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.
Additionally, XARELTO@ is being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. Rivaroxaban is being developed jointly by JRD and Bayer HealthCare. U.S. marketing rights for XARELTO@ are held by Janssen Pharmaceuticals, Inc.
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Important Safety Information WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO @ ? For people taking XARELTO @ for atrial fibrillation: People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body.
XARELTO@ lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO@, you may have an increased risk of forming a clot in your blood.
-- Do not stop taking XARELTO @ without talking to the doctor who prescribes it for you. Stopping XARELTO @ increases your risk of having a stroke or forming blood clots in other parts of your body.
If you have to stop taking XARELTO@, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.
For all people taking XARELTO @ : -- XARELTO@ can cause bleeding which can be serious, and rarely may lead to death. This is because XARELTO@ is a blood thinner that reduces blood clotting. While you take XARELTO@ you are likely to bruise more easily and it may take longer for bleeding to stop.
You may have a higher risk of bleeding if you take XARELTO@ and take other medicines that increase your risk of bleeding including: -- aspirin or aspirin containing products, -- non-steroidal anti-inflammatory drugs (NSAIDs) -- warfarin sodium (Coumadin@, Jantoven@) -- any medicine that contains heparin -- clopidogrel (Plavix@) -- prasugrel (Effient@) -- ticagrelor (Brilinta@) Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding: -- 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 during surgery.
-- any unexpected bleeding, or bleeding that lasts a long time (such as nose bleeds that happen often, unusual bleeding from gums, or menstrual bleeding that is heavier than normal or vaginal bleeding) -- bleeding that is severe or that you cannot control -- red, pink or brown urine -- bright red or black stools (look like tar) -- cough up blood or blood clots -- vomit blood or your vomit looks like "coffee grounds" -- headaches, feeling dizzy or weak -- pain, swelling, or new drainage at wound sites WHO SHOULD NOT TAKE XARELTO @ ? Do not take XARELTO@ if you: -- currently have abnormal or unusual bleeding -- are allergic to rivaroxaban or any of the ingredients of XARELTO@ WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO @ ? Before taking XARELTO@ tell your doctor if you: -- Have ever had bleeding problems -- Have liver or kidney problems -- Have any other medical condition -- Are pregnant or planning to become pregnant -- Are breastfeeding or plan to breastfeed Tell all of your doctors and dentists that you are taking XARELTO@.
They should talk to the doctor who prescribed XARELTO@ for you before you have any surgery, medical or dental procedure.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO@ works. Certain medicines may increase your risk of bleeding.
Especially tell your doctor if you take: -- ketoconazole (Nizoral@) -- itraconazole (OnmelT, Sporanox@) -- ritonavir (Norvir@) -- lopinavir/ritonavir (Kaletra@) -- indinavir (Crixivan@) -- carbamazepine (Carbatrol@, Equetro@, Tegretol@, Tegretol@-XR, TerilT, Epitol@) -- phenytoin (Dilantin-125@, Dilantin@, Phenobarbital, SolfotonT) -- rifampin (Rifater@, Rifamate@, Rimactane@, Rifadin@) -- St. John's wort (Hypericum perforatum) Ask your doctor if you are not sure if your medicine is one listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
HOW SHOULD I TAKE XARELTO @ ? Take XARELTO@ exactly as prescribed by your doctor. Do not change your dose or stop taking XARELTO@unless your doctor tells you to.
For people who have: -- atrial fibrillation: Take XARELTO@ 1 time a day with your evening meal. Stopping XARELTO@may increase your risk of having a stroke or forming blood clots in other parts of your body.
-- hip or knee replacement surgery: Take XARELTO@ 1 time a day with or without food.
-- Your doctor may stop XARELTO@ for a short time before any surgery, medical or dental procedure. Your doctor will tell you when to start taking XARELTO@ again after your surgery or procedure.
-- Do not run out of XARELTO@. Refill your prescription for XARELTO@ before you run out. When leaving the hospital following a hip or knee replacement, be sure that you will have XARELTO@ available to avoid missing any doses.
-- If you miss a dose of XARELTO@, take it as soon as you remember on the same day.
-- If you take too much XARELTO@, go to the nearest hospital emergency room or call your doctor right away.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO @ ? XARELTO@ can cause bleeding which can be serious, and rarely may lead to death. Please see "What is the most important information I should know about XARELTO@?" Tell your doctor if you have any side effect that bothers you or that does not go away.
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).
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