Acute Coronary Syndrome (ACS):
U.S. FDA Issues Complete Response Letter for Bayer’s Xarelto® (Rivaroxaban) for the Reduction of Cardiovascular Events in Patients with ACS
Mar 5th, 2013 - Berlin, Germany – Bayer HealthCare announced today that the U.S.
Food and Drug Administration (FDA) issued a second complete response letter regarding
the supplemental New Drug Application (sNDA) for the oral anticoagulant Xarelto
(rivaroxaban) 2.5 mg BID in combination with standard antiplatelet therapy for the
reduction of cardiovascular events (cardiovascular death, myocardial infarction or stroke)
in patients with Acute Coronary Syndrome (ACS). Bayer is evaluating the complete
response letter from the FDA together with its cooperation partner Janssen Research &
Development, LLC, and will respond to the Agency’s questions.
“We remain confident in the safety and efficacy of rivaroxaban in this indication and will
work closely with our development partner Janssen Research & Development, LLC, to
address the questions from the FDA,” said Dr. Kemal Malik, Member of the Bayer
HealthCare Executive Committee and Head of Global Development.
Xarelto is approved for six clinical uses in the U.S.:
- to reduce the risk of blood clots in the legs and lungs of adults who have just had knee replacement surgery
- to reduce the risk of blood clots in the legs and lungs of adults who have just had hip replacement surgery
- to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in adults with atrial fibrillation not caused by a heart valve problem
- to treat adults with pulmonary embolism (PE) to treat adults with deep vein thrombosis (DVT)
- to reduce the risk of recurrence of DVT or PE following an initial six months of treatment for acute venous thromboembolism
The sNDA includes results from the pivotal, global Phase III ATLAS ACS 2-TIMI 51 study,
which showed that rivaroxaban 2.5 mg dosed twice daily in addition to standard
antiplatelet therapy (low-dose aspirin with or without a thienopyridine such as clopidogrel
or ticlopidine) significantly reduced the composite primary efficacy endpoint of
cardiovascular death, myocardial infarction or stroke in patients after a recent ACS
compared to those receiving standard antiplatelet therapy alone.
Rates of TIMI (Thrombolysis In Myocardial Infarction) major bleeding events not associated with coronary artery bypass graft (CABG) surgery were low overall, but rivaroxaban was associated with higher rates of these bleeds compared with standard therapy alone. Importantly, these differences were not associated with an increase in the risk of fatal bleeding or fatal intracranial haemorrhage (ICH).
About Acute Coronary Syndrome (ACS)
ACS is a complication of coronary heart disease which is the single most common cause
of death worldwide and one of the most prevalent non-communicable diseases in the
world. ACS occurs when a blood clot blocks a coronary artery, reducing blood supply to
the heart. This disruption of blood flow can directly cause a heart attack, or severe pain in
the chest (unstable angina), a condition indicating that a heart attack may soon occur.
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.
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
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Find more information at www.bayerpharma.com.
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.
- 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).
- The ability of a drug to produce the desired effect.
- 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.
- 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.