Bayer’s Novel Anticoagulant Rivaroxaban Recommended for Approval in the EU
Final approval from the European Commission expected within the next few months.
Leverkusen. – The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the anticoagulant rivaroxaban (Xarelto®), taken as one tablet, once-daily, for the prevention of venous blood clots in patients undergoing elective (planned) hip or knee replacement surgery. It is expected that final approval by the European Commission will follow in the next few months, providing marketing authorization for rivaroxaban in all EU member states. 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.
“The recommendation for approval of rivaroxaban by the CHMP marks another significant milestone in our extensive development program. We received it only nine months after the submission – very fast compared to average,” said Dr. Kemal Malik, member of the Bayer HealthCare Executive Committee, responsible for product development. “Rivaroxaban has demonstrated its significant clinical potential in a ground-breaking study program and we are looking forward to providing this innovative treatment alternative to patients in Europe very soon.”
“The limitations of current treatment standards mean that many orthopaedic surgery patients still do not receive satisfactory anticoagulant therapy to prevent potentially fatal blood clots,” commented Dr. Bengt Eriksson, Orthopaedic Surgeon at the Sahlgrenska University Hospital/Östra, Gothenburg, Sweden, and Principal Investigator of the RECORD1 clinical trial. “The results of the rivaroxaban Phase III RECORD studies are indeed very positive and rivaroxaban has the potential to change standard practice in the prevention of deep vein thrombosis and pulmonary embolism.”
The positive opinion was received from the CHMP after the Committee reviewed data from the extensive RECORD clinical program that included three Phase III trials of rivaroxaban involving nearly 10,000 patients undergoing elective hip or knee replacement surgery (RECORD1, 2 and 3 trials). Results from these three studies demonstrated the superior efficacy of rivaroxaban, both in head-to-head comparisons with enoxaparin (RECORD1 and 3), and when comparing extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin (RECORD2). In all three trials, rivaroxaban and enoxaparin had comparable safety profiles including similar low rates of major bleeding.
To date, Bayer HealthCare has submitted regulatory filings in more than 10 other countries, including Canada and China. Rivaroxaban is expected to be filed for approval in the U.S. shortly, and on approval, Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market the drug in the U.S.
The extensive clinical trial program supporting rivaroxaban makes it the most studied oral direct Factor Xa inhibitor in the world today. Almost 50,000 patients are expected to be enrolled overall into the rivaroxaban clinical development program which will evaluate the product in the prevention and treatment of a broad range of acute and chronic blood-clotting disorders such as VTE treatment, stroke prevention in patients with atrial fibrillation, VTE prevention in hospitalized, medically ill patients and secondary prevention of acute coronary syndrome.
In the EU, there are in excess of 1.5 million blood clot events annually and these are responsible for killing 544,000 people each year – more than breast cancer, prostate cancer, HIV/AIDS and road traffic accidents combined. Please visit www.thrombosisadviser.com to learn more about VTE.
Bayer estimates the global peak sales potential of rivaroxaban for all indications to exceed EUR 2 billion.
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