New Drug Application for Rivaroxaban in the U.S.:
Update on Status of Rivaroxaban Complete Response Letter From U.S. FDA
Jul 14th, 2009 - Leverkusen: Bayer Schering Pharma AG, Germany, announced today
that its partner, Ortho-McNeil, does not expect to submit its complete response to the U.S.
Food and Drug Administration (FDA) until the fourth quarter of this year, at the earliest.
“We are fully convinced of the positive risk-benefit profile of rivaroxaban, which has been
approved in more than 60 countries worldwide in its first indication, and there are no new
data in the clinical trials database that would change this assessment,” said Kemal Malik,
member of the Bayer HealthCare Executive Committee and Chief Medical Officer. “We
want to take the time to diligently respond to all the questions raised by the FDA in the
Complete Response Letter and are confident that, together with our partner, Ortho-
McNeil, we can provide all information necessary for an approval of rivaroxaban in the
While no new clinical or non-clinical studies to evaluate the efficacy or safety of
rivaroxaban were requested by the FDA as a pre-requisite for approval, the FDA has
asked the company to submit additional data from completed and ongoing studies of
rivaroxaban, and from market surveillance from those countries outside the U.S. where
the drug is currently sold to further assess the risk-benefit profile of the drug. The FDA
also asked for additional information on RECORD study sites.
Additional meetings between Ortho-McNeil and the FDA are planned this summer to
agree on a plan to adequately address the points raised by the FDA in its complete
response letter. The outcome of those discussions will be a key determinant in
establishing the eventual timeline for submission of the complete response.
Rivaroxaban is a novel, oral anticoagulant currently under FDA review as one tablet,
once-daily for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism
(PE) in patients undergoing hip or knee replacement surgery. The NDA for rivaroxaban
was submitted by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.,
on behalf of Ortho-McNeil Inc., on July 28, 2008. In March 2009, an FDA Advisory
Committee agreed by a vote of 15-2 that the available clinical data for rivaroxaban
demonstrated a favorable risk-benefit profile.
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.
Unmet Needs in Venous Thromboembolism (VTE)
Blood clots can break apart and travel through the bloodstream, blocking blood flow to
vital organs. VTE includes DVT, a blood clot in a deep vein (usually in the leg), and PE, a
blood clot in the lung, both of which are serious, life-threatening – but often preventable –
conditions. Patients undergoing major orthopedic surgery are at high risk for VTE
because during hip or knee replacement procedures, the large veins of the leg that carry
blood back to the heart can be damaged, significantly increasing the risk of developing a
clot. In fact, venous blood clots occur in 40-60 percent of patients undergoing major
orthopedic surgery who do not receive preventive care. Each year, approximately 800,000
Americans elect to have hip or knee replacement surgeries, and VTE is the most common
cause of re-hospitalization for this patient group.
Rivaroxaban was invented in Bayer’s Wuppertal laboratories in Germany, and is being
jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research
& Development, L.L.C. Rivaroxaban is approved in the European Union for the prevention
of VTE in adult patients undergoing elective hip or knee replacement surgery, where it is
marketed under the brand name Xarelto®. Additional approvals have been granted in
other countries, including Australia, Canada, China, Mexico and Singapore. To date,
Xarelto has been launched in more than 40 countries around the world by Bayer
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 expected to be
enrolled into the rivaroxaban clinical development program, which will evaluate the
product in the prevention and treatment of a broad range of acute and chronic bloodclotting
disorders, including VTE treatment, stroke prevention in patients with atrial
fibrillation, secondary prevention of acute coronary syndrome, and VTE prevention in
hospitalized, medically ill patients.
To learn more about thrombosis, please visit www.thrombosisadviser.com
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 subsidiary of Bayer AG, 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, Bayer Schering Pharma, Consumer Care and Medical
Care divisions. Bayer HealthCare’s aim is to discover and manufacture products that will
improve human and animal health worldwide. Find more information at
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas: Diagnostic
Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative
products, Bayer Schering Pharma aims for leading positions in specialized markets
worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to
medical progress and strives to improve the quality of life.
Find more information at www.bayerscheringpharma.de.
Astrid Kranz, Tel.: +49 30-468-12057
Alexander Siedler, Tel.: +49 30-468-12727
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.
- 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.
- 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).
- 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.