Low-dose rivaroxaban given fast track designation by U.S. FDA as first novel oral anticoagulant to be evaluated in this high-risk patient group
New Pivotal Phase III Study Initiated with Bayer’s Xarelto® (Rivaroxaban) in Patients with Chronic Heart Failure and Significant Coronary Artery Disease
Mar 8th, 2013 - Berlin, Germany – Bayer HealthCare and its cooperation partner Janssen Research & Development, LLC announced today the initiation of COMMANDERHF, a pivotal Phase III clinical trial that will evaluate Xarelto (rivaroxaban) 2.5 mg twice daily in patients with chronic heart failure (HF) and significant coronary artery disease (CAD). Rivaroxaban is the first novel oral anticoagulant to be evaluated in this patient group who remain at high-risk for complications following hospitalization for exacerbation of their HF.
Heart failure poses a major public health problem worldwide.i It is one of the most common reasons for hospitalization in the developed world and places a major burden on hospital staff and resources.ii In the U.S. and Europe, three-quarters of all patients hospitalized with heart failure for the first time will die within five years.iii
“COMMANDER-HF will assess whether the addition of low-dose rivaroxaban on top of
standard therapy can help reduce the risk of death, heart attack or stroke in this high-risk
patient group following hospitalization,” said Dr. Kemal Malik, Member of the Bayer
HealthCare Executive Committee and Head of Global Development.
The U.S. Food and Drug Administration granted a fast track designation process for the
COMMANDER-HF study to help facilitate the development process, and expedite the
review of rivaroxaban in this indication.
The trial will assess the safety and efficacy of 2.5 mg twice daily rivaroxaban compared to
placebo (on a background of standard treatment) in reducing the risk of death, myocardial
infarction (MI) or stroke in 5,000 patients with chronic HF and significant CAD following
hospitalization. The primary efficacy outcome is the composite of all-cause mortality, MI,
or stroke. The principal safety outcome is the composite of fatal bleeding or bleeding into
a critical space with a potential for permanent disability.
Xarelto has the broadest indication profile of any of the newer oral anticoagulants. To
date, Xarelto is approved for six distinct uses in the venous arterial thromboembolic (VAT)
About Venous and 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 and 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 is approved for six distinct uses in 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
- The treatment of deep vein thrombosis (DVT) in adults
- The treatment of pulmonary embolism (PE) in adults
- The prevention of recurrent DVT and PE in adults
- The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery
- The prevention of venous thromboembolism (VTE) in adult patients undergoing elective knee replacement surgery
Whilst licences may differ from country to country, across all indications Xarelto is
approved in more than 120 countries.
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
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 18.6 billion (2012), 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 55,300 employees (Dec
31, 2012) and is represented in more than 100 countries. More information at
Our online press service is just a click away: press.healthcare.bayer.com.
Astrid Kranz, Tel. +49 30 468-12057
Stephanie Prate, Tel. +49 30 468-196053
Find more information at www.bayerpharma.com.
i McMurray JJV, et al. The burden of heart failure. European Heart Journal Supplements (2002) 4 (Supplement D), D50-D58.
ii Cowie MR, et al. Hospitalization of patients with heart failure. European Heart Journal (2002) 23, 877–885,
iii McMurray JJV, et al. The burden of heart failure. European Heart Journal Supplements (2002) 4 (Supplement D), D50-D58.
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.
- The ability of a drug to produce the desired effect.
- Formation of a clot inside a blood vessel.
- 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).
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- 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.
- 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.