Press Release
Bayer’s Xarelto® (Rivaroxaban) Recommended for EU Approval for the Treatment of Pulmonary Embolism (PE) and Prevention of Recurrent Deep Vein Thrombosis (DVT) and PE
- Rivaroxaban offers the first oral single-drug solution for the treatment of PE and long-term prevention of DVT and PE
- Decision of European Commission on approval expected before year-end
Oct 19th, 2012 - Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults. The decision of the European Commission on the approval is expected before the year-end.
“Rivaroxaban is the novel oral anticoagulant with the broadest range of indications. The recommendation by the CHMP to approve rivaroxaban for this additional use is an important milestone towards improved patient management in the treatment of pulmonary embolism,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development.
The CHMP recommendation to approve rivaroxaban for the treatment of PE and the prevention of recurrent DVT and PE in adults is based on the important clinical findings from the pivotal, global Phase III EINSTEIN-PE study. With 4,833 patients enrolled, EINSTEIN-PE is the largest study ever conducted in the acute treatment of PE. The study compared the oral single-drug solution of rivaroxaban 15 mg twice daily for three weeks followed by 20 mg once daily with the current dual drug approach of subcutaneous enoxaparin followed by a VKA. Patients were treated for either three, six or 12 months. Rivaroxaban demonstrated efficacy comparable to that of the current standard therapy in reducing the primary endpoint of recurrent symptomatic VTE, a composite of symptomatic deep vein thrombosis (DVT) and non-fatal or fatal PE, without the need for laboratory monitoring. The overall bleeding rates were similar between the treatment groups, but importantly rivaroxaban was associated with significantly lower rates of major bleeding. The results from this study were published in the New England Journal of Medicine in April this year.
EINSTEIN-PE is one of three Phase III studies in the global EINSTEIN program that evaluated the safety and efficacy of rivaroxaban in the treatment of venous thromboembolism in almost 10,000 patients. The other two trials – EINSTEIN-DVT and EINSTEIN-EXT – were published together in the New England Journal of Medicine in December 2010. In December 2011, Xarelto (rivaroxaban) received European Commission approval for the treatment of DVT and the prevention of recurrent DVT and PE following an acute DVT in adults.
About Venous Arterial Thromboembolism (VAT)
Thrombosis is the formation of a blood clot inside a blood vessel, blocking a vein (venous thrombosis) or artery (arterial thrombosis). Venous Arterial Thromboembolism (VAT) is caused when some or all of a clot detaches and is moved within the blood stream until it obstructs a smaller vessel. This can result in damage to vital organs, because the tissue beyond the blockage no longer receives nutrients and oxygen.
VAT is responsible for a number of serious and life threatening conditions:
- Venous Thromboembolism (VTE) occurs when part of a clot formed in a deep vein, for example in the leg (known as deep vein thrombosis, or DVT), is carried to the lung, via the heart, preventing the uptake of oxygen. This is known as a pulmonary embolism (PE), an event which can be rapidly fatal
- Arterial Thromboembolism (ATE) occurs when oxygenated blood flow from the heart to another part of the body (via an artery) is interrupted by a blood clot. If this occurs in a vessel supplying blood to the brain, it can lead to a stroke, an event that can be severely debilitating or fatal. If it occurs in a coronary artery, it can lead to acute coronary syndrome (ACS), a complication of coronary heart disease which includes conditions such as myocardial infarction (heart attack), and unstable angina
VAT is responsible for significant morbidity and mortality, and requires active or preventative treatment to avoid potentially serious or fatal patient outcomes.
To learn more about VAT, please visit www.VATspace.com
About Xarelto (Rivaroxaban)
Rivaroxaban is the most broadly indicated new oral anticoagulant and is marketed under the brand name Xarelto. To date, Xarelto has been approved for use in the following indications across the venous arterial thromboembolic (VAT) space:
- The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors in more than 70 countries worldwide
- The treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) in adults in more than 70 countries worldwide
- The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery in more than 120 countries worldwide
Since the first approval of Xarelto in 2008 in the orthopaedic setting, more than two and a half million patients worldwide have received Xarelto in daily clinical practice.
Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company).
Anticoagulant medicines are potent therapies used to prevent or treat serious illnesses and potentially life-threatening conditions. Before initiating therapy with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.
Responsible use of Xarelto is a very high priority for Bayer, and the company has developed a Prescribers Guide for physicians and a Xarelto Patient Card for patients to support best practice.
To learn more, please visit: www.prescribe.xarelto.com
To learn more about thrombosis, please visit www.thrombosisadviser.com
To learn more about Xarelto, please visit www.xarelto.com
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), 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, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2011) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.
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Find more information at www.bayerpharma.com.
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Forward-Looking Statements
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.
- Thrombosis
- Formation of a clot inside a blood vessel.
- 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.
- Efficacy
- The ability of a drug to produce the desired effect.
- Subcutaneous
- Introduced beneath the skin.
- 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.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- Vitamin K antagonist
- An anticoagulant that inhibits multiple steps in the blood clotting process. Administered orally, the dose varies by patient, and regular monitoring and dose adjustment is required. Vitamin K antagonists have interactions with food and other drugs. Due to the many limitations of this drug, many patients are actually not treated and many of those who are treated are outside of the required target INR range, which can be the cause for increased bleeding or a greater risk of stroke.
- 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.
