FDA Grants Review for XARELTO Supplemental NDAs,.
DVT is a condition in which blood clots form in one of the large, deep veins, usually in the legs. PE is a serious condition that most commonly occurs when part or all of a DVT dislodges and is carried to the lung, via the heart, where it can partially or completely block a branch of the pulmonary artery.
"We are delighted to have received a priority review designation for XARELTO for the treatment of PE and DVT, and also to prevent the recurrence of these conditions. Each year an estimated 900,000 Americans experience a DVT or PE, and one third of those events are fatal. If approved for these indications, XARELTO^A[R] has the potential to address critical unmet needs in treating patients with these serious medical conditions," said Paul Burton, M.D., Ph.D., Vice President, Cardiovascular Franchise Medical Leader at Janssen R&D.
The FDA grants priority review to medicines that offer major advances in care or provide a treatment where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), FDA will aim to complete its review within six months from the receipt of the sNDA submission, rather than the standard 10 month review cycle.
The submissions are supported by data from the global EINSTEIN program, which includes two Phase 3 studies evaluating the safety and efficacy of rivaroxaban in the treatment of patients with acute symptomatic DVT or PE and the prevention of recurrent events in these patients. A third Phase 3 study evaluated the safety and efficacy of rivaroxaban in the long-term prevention of recurrent DVT and PE. In total, these Phase 3 studies included more than 9,400 patients.
Separately, Janssen R&D announced it is withdrawing the sNDA for the use of XARELTO^A[R] to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome (ACS). The company is withdrawing this sNDA because it is contingent on a separate sNDA, for XARELTO^A[R] to reduce of the risk of secondary cardiovascular events in patients with ACS, which Janssen R&D received a complete response letter from the FDA on June 21, 2012. Data from the ATLAS ACS 2 TIMI 51 trial support both sNDAs.
"We remain confident in the overall study results from the ATLAS ACS 2 TIMI 51 trial, including the observed reduction in stent thrombosis that formed the basis for this separate sNDA," said Dr. Burton. "Our top priority is to work with FDA on our original sNDA for ACS and submit our reply to the complete response letter as soon as possible. We plan to resubmit the sNDA for stent thrombosis at the same time."
Stent thrombosis is an uncommon, but potentially catastrophic complication that may occur after a stent has been inserted into a patient's coronary artery and can result in a heart attack or even death. Coronary stents are implanted in more than 1.5 million patients each year.
About XARELTO (rivaroxaban)
*Unlike other oral anticoagulants on the U.S. market, only XARELTO^A[R] works by blocking the blood clotting Factor Xa. XARELTO^A[R] does not require routine blood monitoring, and is approved for three uses: to reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery, to reduce this risk in people who have just had 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 XARELTO^A[R] 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.
XARELTO has the broadest indication profile of any of the newer oral anticoagulants either in market today or coming to the U.S. market in the foreseeable future, and is broadly available for more than 90% of commercial and Medicare health plan members. To date, more than 1.5 million patients have received XARELTO^A[R] worldwide and more than 387,000 prescriptions have been written for XARELTO^A[R] in the U.S. alone.
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 75,000 patients will have participated in the rivaroxaban clinical development program. There are four filings currently submitted to the FDA. Three are under review and the fourth, for the ACS indication, is pending reply to the complete response letter. Rivaroxaban is being developed jointly by Janssen R&D and Bayer HealthCare. U.S. marketing rights for XARELTO 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 http://www.janssenrnd.com for more information.
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^A[R] lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO^A[R] , you may have an increased risk of forming a clot in your blood.
Do not stop taking XARELTO^A[R] without talking to the doctor who prescribes it for you. Stopping XARELTO^A[R] 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^A[R] is a blood thinner that reduces blood clotting. While you take XARELTO^A[R] 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^A[R] and other medicines that increase your risk of bleeding including:
* aspirin or aspirin containing products,
* non-steroidal anti-inflammatory drugs (NSAIDs)
* warfarin sodium (Coumadin^A[R] , Jantoven^A[R] )
* any medicine that contains heparin
* clopidogrel (Plavix^A[R] )
* prasugrel (Effient^A[R] )
* ticagrelor (Brilinta^A[R] )
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
*W* *HO SHOULD NOT TAKE XARELTO^A[R] ? *Do not take XARELTO^A[R] if you:
* currently have abnormal or unusual bleeding * are allergic to rivaroxaban or any of the ingredients of XARELTO^A[R]
*WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO^A[R] ? *Before taking XARELTO^A[R] 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^A[R] . They should talk to the doctor who prescribed XARELTO^A[R] 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^A[R] works. Certain medicines may increase your risk of bleeding.
Especially tell your doctor if you take:
* ketoconazole (Nizoral^A[R] ) * itraconazole (Onmelacents, Sporanox^A[R] ) * ritonavir (Norvir^A[R] ) * lopinavir/ritonavir (Kaletra^A[R] ) * indinavir (Crixivan^A[R] ) * carbamazepine (Carbatrol^A[R] , Equetro^A[R], Tegretol^A[R] , Tegretol^A[R] -XR, Terilacents, Epitol^A[R] ) * phenytoin (Dilantin-125^A[R] , Dilantin^A[R] , Phenobarbital, Solfotonacents) * rifampin (Rifater^A[R] , Rifamate^A[R] , Rimactane^A[R] , Rifadin^A[R] ) * 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^A[R] ? *Take XARELTO^A[R] exactly as prescribed by your doctor. *Do not change your dose or stop taking XARELTO^A[R] unless your doctor tells you to.*
For people who have: atrial fibrillation:* Take XARELTO^A[R] 1 time a day *with* *your evening meal*. *Stopping XARELTO^A[R] 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^A[R] 1 time a day *with or without food*.
* Your doctor may stop XARELTO^A[R] for a short time before any surgery, medical or dental procedure. Your doctor will tell you when to start taking XARELTO^A[R] again after your surgery or procedure.
* Do not run out of XARELTO^A[R] . Refill your prescription for XARELTO^A[R] before you run out. When leaving the hospital following a hip or knee replacement, be sure that you will have XARELTO^A[R] available to avoid missing any doses.
* If you miss a dose of XARELTO^A[R] , take it as soon as you remember on the same day.
* If you take too much XARELTO^A[R] , go to the nearest hospital emergency room or call your doctor right away.
*WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO^A[R] ? *XARELTO^A[R] 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^A[R] ?"/
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).
*Media contacts: * Ernie Knewitz Phone: 908.927.2953 Mobile: 917.697.2318 firstname.lastname@example.org <mailto:email@example.com>
Shaun Mickus Phone: 908.927.2416 Mobile: 973.476.7144 firstname.lastname@example.org <mailto:email@example.com>
*Investor contacts: * Stan Panasewicz Phone: 732.524.2524
Louise Mehrotra Phone: 732.524.6491
SOURCE Janssen Research & Development, LLC
Web Site: http://www.janssenrnd.com >TI Terumo Completes Enrollment in OSPREY Trial to Evaluate Stent >TX Terumo Interventional Systems, a strategic business unit of Terumo Medical Corporation, a U.S. subsidiary of Terumo Corporation, has announced the completion of U.S. patient enrollment in the */O/ * /cclusive/*S*tenotic *P*eripheral Artery *RE*vascularization Stud*Y* / (OSPREY) designed to evaluate the safety and effectiveness of the MISAGO Self-expanding Stent System. OSPREY is a single-arm, multi-center, non-randomized prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the superficial femoral artery that included 200 patients in 31 centers in the U.S. and 100 patients in seven centers in Japan.
A unique feature of this landmark study is that it simultaneously enrolled patients in the U.S. and Japan as part of the larger /Harmonization by Doing/ (HBD) pilot program, a cooperative effort led by the U.S. Food & Drug Administration, the MHLW/PMDA (Japan's regulatory body), Terumo Corporation, based in Tokyo, Japan, and Terumo Medical Corporation, based in Somerset, New Jersey. The HBD initiative is intended to shorten the gap between product approvals in these two significant world healthcare markets.
"OSPREY is Terumo Medical Corporation's first U.S. clinical trial for a premarket approval (PMA) device and we are exceptionally pleased with its progress. Terumo is greatly appreciative of the tremendous support given by our U.S. clinical investigators, which helped us meet the critical enrollment goal in this landmark HBD initiative," said James Rushworth, President of Terumo Interventional Systems and Onset Medical Corporation. "The OSPREY trial and the MISAGO Stent truly speak to our three strategic pillars of introducing innovative technologies that create Clinical, Economic, and Quality of Life Benefits."
The MISAGO Self-expanding Stent consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system. The stent has three radiopaque markers located on each end of the stent to help ensure accurate placement in the lesion. The stent is currently available for sale in Europe.
The first U.S. patient implant in the OSPREY trial occurred in September 2010. The primary endpoints of the U.S. arm of the OSPREY study are:
* Primary stent patency rate at one year as confirmed by duplex ultrasound or angiography.
* Freedom from major adverse events within 30 days of the procedure, which would result in target lesion revascularization, amputation of the treated limb or death.
"Peripheral vascular disease is a leading cause of disability in the U.S., affecting between 8 and 12 million Americans. It is critical that physicians, and their patients, have faster access to the latest technologies in order to maximize treatment options," said J. Fritz Angle, MD, Professor of Radiology, University of Virginia, and U.S. Principal Investigator in the OSPREY trial. "I look forward to analyzing and discussing the OSPREY data with all of the trial investigators. The international experience and testing efficiencies obtained from our collective participation in this HBD initiative could have a dramatic effect on the way important medical devices reach the market in the future."
For more information about the OSPREY trial, contact Joanna Murray, Clinical Project Manager, Terumo Interventional Systems, 732-302-4900, extension 7210.
*Terumo Interventional Systems *Terumo Interventional Systems (TIS) is a strategic business unit of Terumo Medical Corporation. As a market leader in entry site management and lesion access, TIS is committed to pursuing unique technologies designed to enhance treatment of coronary and peripheral endovascular diseases as well as driving strategic initiatives focused on Critical Limb Ischemia, Complex Coronary Intervention and Transradial Access. TIS directly markets a full line of guidewires, catheters, introducer sheaths, guiding sheaths and embolization products for use in a multitude of different interventional procedures.
Terumo Medical Corporation
Founded in 1972 as a Terumo Corporation subsidiary, Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC is comprised of two business divisions: Terumo Interventional Systems and Terumo Medical Products. The company places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved Quality of Life for patients.
Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with $5 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures, and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures, and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use. Terumo contributes to society by providing valued products and services to the healthcare market and by responding to the needs of healthcare providers and the people they serve.
Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.
SOURCE Terumo Interventional Systems
CONTACT: Robert Murphy, The Storch-Murphy Group, +1-908-276-0777, firstname.lastname@example.org >TI GE Healthcare Selects PS320 Fetal Simulator >TX Fluke Biomedical has announced that GE Healthcare has selected the PS320 Fetal Simulator <http://www.flukebiomedical.com/PS320> to help maintain their fleet of Corometrics 250, 250cx and 170 series patient monitors. The pocket-sized PS320 simulates both fetal and maternal ECG as well as uterine activity to ensure proper function of fetal monitors.
The PS320 Fetal Simulator signals a variety of physiological parameters, patterns and conditions and is unique in its ability to simulate twins. An optional mechanical heart creates fetal heart sounds for testing fetal monitor ultrasound cables and transducers. Ideal for preventive maintenance testing, troubleshooting and repairs, the PS320 is also a favorite for simulating a wide range of clinical scenarios for training labor-and-delivery staff in how to recognize normal and abnormal responses between mother, fetus and monitor.
"We're delighted to hear GE Healthcare has selected the PS320 Fetal Simulator to test their fleet of Corometrics fetal monitors," noted Christopher Rayburn, Director of Marketing for Fluke Biomedical. "Our companies are both known for best-in-class equipment and time-tested dedication to patient safety."
For more information on the PS320 Fetal Simulator, visit http://www.flukebiomedical.com/PS320.
*About Fluke Biomedical
*Fluke Biomedical is the premiere, global provider of test and measurement equipment and services to the healthcare industry. We strive to be the best at delivering innovative solutions to improve quality of global health. We serve biomedical engineers, quality-assurance technicians, medical physicists, oncologists and radiation-safety professionals and are continually expanding our range of solutions to a broader range of health and safety professionals.
For more information, visit http://www.flukebiomedical.com or call 425/446-5494. >EN
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|Publication:||Biotech Equipment Update|
|Date:||Aug 1, 2012|
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