Bayer’s Rivaroxaban Submitted for EU Marketing Authorisation in Stroke Prevention in Patients with Atrial Fibrillation as well as for the Treatment of Deep Vein Thrombosis (DVT) and Prevention of Recurrent DVT and Pulmonary Embolism (PE)
- Submission in Stroke Prevention in Patients with Atrial Fibrillation (AF) based on positive results of ROCKET AF trial in more than 14,000 patients
- Submission in Treatment of DVT and Prevention of Recurrent DVT and PE based on positive results of EINSTEIN-DVT and EINSTEIN-Extension clinical studies in more than 4,500 patients
Jan 5th, 2011 - Berlin, Germany – Bayer has submitted an application for marketing authorization to the European Medicines Agency (EMA) for the oral anticoagulant rivaroxaban in stroke prevention in patients with atrial fibrillation (SPAF), as well as for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE). Rivaroxaban is an oral direct Factor Xa inhibitor, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD).
The submission for stroke prevention in patients with AF is supported by data from the pivotal, global Phase III ROCKET AF trial that was presented at the American Heart Association (AHA) Congress in November 2010.
Submission for the treatment of DVT, and prevention of recurrent DVT and PE, is based on data from the Phase III EINSTEIN-DVT trial that was presented at the European Society of Cardiology (ESC) Congress in August 2010, and data from the Phase III EINSTEIN-Extension trial that was presented in December 2009 at the 51st Annual Meeting of the American Society of Hematology (ASH). The EINSTEIN-DVT and EINSTEIN-Extension data have recently been published in the New England Journal of Medicine (NEJM).
ROCKET AF, EINSTEIN-DVT and EINSTEIN-Extension are part of the global development program that has demonstrated the benefit of rivaroxaban in the seven Phase III studies completed to date.
Bayer also confirmed that J&JPRD filed its complete response with the U.S. Food & Drug Administration (FDA) seeking approval to use rivaroxaban for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing total hip or total knee replacement surgery. The filing includes specific information requested by the FDA in a Complete Response Letter on May 28, 2009, and is primarily supported by data from the pivotal, global Phase III RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program.
If approved by the FDA, Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company), 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.
Rivaroxaban is an oral anticoagulant that was invented in Bayer HealthCare’s Wuppertal laboratories in Germany, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. It has a rapid onset of action with a predictable dose response and high bioavailability, no requirement for coagulation monitoring, as well as a limited potential for food and drug interactions.
Rivaroxaban is marketed under the brand name Xarelto® for VTE prevention in adult patients following elective hip or knee replacement surgery, and it is the only oral anticoagulant that has consistently demonstrated superior efficacy over enoxaparin for this indication. Xarelto is approved in more than 100 countries worldwide and has been successfully launched in more than 75 countries 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 65,000 patients are participating in the rivaroxaban clinical development program evaluating the product in the prevention and treatment of a broad range of acute and chronic blood-clotting disorders, including VTE prevention in medically ill patients, VTE treatment, and secondary prevention of acute coronary syndrome.
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 subgroup of Bayer AG with annual sales of EUR 15,988 million (2009), 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, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 53,400 employees and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.
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- 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.
- Formation of a clot inside a blood vessel.
- 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.
- The ability of a drug to produce the desired effect.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- 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).