Venous Blood Clot Prevention after Hip or Knee Replacement Surgery:
U.S. FDA Advisory Committee supports favorable benefit-risk profile of Bayer’s rivaroxaban
Mar 19th, 2009 - 19th March 2009 - Leverkusen: An Advisory Committee to the U.S. Food and Drug Administration (FDA) met today to discuss the new drug application (NDA) for Bayer’s rivaroxaban, a novel, oral anticoagulant taken as one tablet, once-daily for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery. The FDA utilized the expertise of the Advisory Committee members as part of their review process, and asked the committee members to address a number of scientific and clinical questions. At the end of the meeting, the Advisory Committee agreed by a vote of 15-2 that “available clinical data demonstrated a favorable risk-benefit profile”.
“Today’s scientific discussion was highly productive, and we are very pleased that the panel recognized the strong dataset which supports the favorable benefit-risk profile of rivaroxaban,” said Dr. Kemal Malik, member of the Bayer HealthCare Executive Committee and Chief Medical Officer.
Data presented at today’s Advisory Committee meeting included results from the global RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program, which involved more than 12,500 patients in four Phase III studies. The studies compared oral rivaroxaban with injected enoxaparin for the prevention of venous thromboembolism (VTE), which comprises DVT and PE, in patients undergoing either total hip (RECORD1 and 2) or total knee (RECORD3 and 4) replacement surgery. The RECORD1, 2 and 3 studies compared rivaroxaban, dosed 10 mg once-daily, against enoxaparin dosed once-daily at 40 mg. RECORD4 evaluated rivaroxaban (10 mg once-daily) against the U.S.-approved dosing regimen for enoxaparin for knee replacement surgery (30 mg twice-daily).
“The data from the RECORD trials show a greater relative risk reduction for rivaroxaban versus the comparator, enoxaparin, in preventing total VTE after total hip and knee replacement surgery,” said Dr. A.G.G. Turpie, Principal Investigator in the RECORD program, Professor of Medicine, McMaster University, Canada. “The committee’s positive vote concerning benefit-risk supports rivaroxaban’s potential to reduce patients’ risk of complications after such surgery.”
The NDA for rivaroxaban was submitted by Johnson & Johnson Pharmaceutical
Research & Development, L.L.C. on July 28, 2008. The Advisory Committee’s
recommendations are not binding, but FDA reviewers will consider the panel’s
recommendation in its assessment of the NDA for rivaroxaban. If approved by the FDA, Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will commercialize rivaroxaban in the U.S. The U.S. Bayer HealthCare sales force will support the Ortho-McNeil sales force by detailing rivaroxaban in designated hospital accounts. Bayer HealthCare is exclusively responsible for the marketing of rivaroxaban in countries outside the U.S.
Unmet Needs in Venous Thromboembolism (VTE)
Blood clots can break apart and travel through the bloodstream, blocking blood flow to vital organs. VTE includes DVT, a blood clot in a deep vein (usually in the leg), and PE, a blood clot in the lung, both of which are serious, life-threatening – but often preventable – conditions. Patients undergoing major orthopedic surgery are at high risk for VTE because during hip or knee replacement procedures, the large veins of the leg that carry blood back to the heart can be damaged, significantly increasing the risk of developing a
clot. In fact, venous blood clots occur in 40-60 percent of patients undergoing major orthopedic surgery who do not receive preventive care. Each year, approximately 800,000 Americans elect to have hip or knee replacement surgeries, and VTE is the most common cause of re-hospitalization for this patient group.
Rivaroxaban was invented in Bayer’s Wuppertal laboratories in Germany, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Rivaroxaban is approved in the European Union for the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery, where it is marketed under the brand name Xarelto®. Additional approvals have been granted in other countries, including Australia, Canada, Mexico and Singapore. To date, Xarelto has been launched in more than 20 countries around the world by Bayer HealthCare.
The extensive clinical trial program supporting rivaroxaban makes it the most studied oral, direct Factor Xa inhibitor in the world today. More than 60,000 patients are expected to be enrolled into the rivaroxaban clinical development program, which will evaluate the product in the prevention and treatment of a broad range of acute and chronic bloodclotting disorders, including VTE treatment, stroke prevention in patients with atrial fibrillation, secondary prevention of acute coronary syndrome, and VTE prevention in hospitalized, medically ill patients.
To learn more about thrombosis, please visit www.thrombosisadviser.com
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.
Find more information at www.bayerscheringpharma.de.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
- Formation of a clot inside a blood vessel.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- Deep vein thrombosis
- A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
- Pulmonary embolism
- A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
- Relative Risk Reduction
- Proportion of the control group experiencing a given outcome minus the proportion of the treatment group experiencing the outcome, divided by the proportion of the control group experiencing the outcome.
- Acute coronary syndrome
- An umbrella term used to cover any group of clinical symptoms compatible with an acute heart attack. The subtypes of acute coronary syndrome include unstable angina (in which the heart muscle is not damaged), and two forms of heart attack in which the heart muscle is damaged. These latter types are named according to the appearance of the electrocardiogram as non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI).
- Atrial fibrillation
- A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
- Factor Xa
- Pivotal component of blood clotting cascade. Stimulates the production of thrombin, the enzyme in the coagulation cascade that promotes the formation of blood clots.