U.S. FDA Approves Xarelto® (Rivaroxaban) to Treat Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) as well as to Reduce the Risk of Recurrent Events
- Rivaroxaban is the only oral single-drug solution proven effective for the treatment of DVT and PE
Nov 2nd, 2012 - Berlin, Germany - Bayer HealthCare announced today that the U.S.
Food and Drug Administration (FDA) has approved the oral anticoagulant Xarelto
(rivaroxaban) for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE),
and to reduce the risk of recurrent DVT and PE.
Rivaroxaban was approved by the FDA on a priority review timeline, making it the only
novel oral anticoagulant approved and the first oral single-drug solution proven effective
for the treatment of DVT and PE in the U.S.
“Xarelto provides a single-drug treatment option from the moment of diagnosis through
the completion of therapy, and in the initial treatment phase, it can cut a patient’s risk of
major bleeding by nearly half,” said Jack E. Ansell, M.D., MACP, Professor of Medicine at
New York University School of Medicine and Chairman of the Department of Medicine at
Lenox Hill Hospital in New York. “Venous blood clots are associated with a high risk of
serious complications, so the approval of Xarelto will immediately impact how we treat
these patients and may set a new standard of care.”
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 travels to the lung, via the heart, where it can partially or completely block a
branch of the pulmonary artery. When PE occurs with large clots, multiple clots, or when
the patient has pre-existing heart or lung disease, the event may be fatal.
“Before the approval of Xarelto, a patient who presented with a DVT or a PE would face a
treatment that involved multiple medications,” said Dr. Kemal Malik, Member of the Bayer
HealthCare Executive Committee and Head of Global Development. “Today’s FDA
approval of Xarelto offers physicians an effective, well-tolerated and convenient singledrug
solution for treating patients with venous blood clots, and for reducing the risk of
Rivaroxaban is approved to treat patients with DVT or PE at a dose of 15 mg twice daily
for three weeks, followed by 20 mg once daily for the remaining treatment period.
Rivaroxaban is also approved to reduce the risk of recurrent episodes of DVT and PE at a
dose of 20 mg once daily following an initial six months of treatment for acute venous
The approval of rivaroxaban for these new uses was based on data from the global
EINSTEIN program, which included three Phase III studies that demonstrated the efficacy
and safety profile of rivaroxaban in the treatment of patients with acute symptomatic DVT
or PE and the long-term prevention of recurrent DVT and PE in these patients. In total,
the program included almost 10,000 patients, making it the largest DVT- and PEtreatment-
related clinical trial program ever conducted.
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 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 is approved for use in the following venous
arterial thromboembolic (VAT) indications:
- 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, more than two and a half million patients
worldwide have now received Xarelto in daily clinical practice.
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
Responsible use of Xarelto is a high priority for Bayer, and the company has developed a
Prescribers Guide for physicians and a Xarelto Patient Card for patients to support best
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
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- 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.
- 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.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.