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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 hip or knee replacement surgery.
It is expected that final approval by the European Commission will follow in the next few months, providing marketing authorisation for rivaroxaban in all EU member states.
“The recommendation for approval of rivaroxaban by the CHMP marks another significant milestone in our extensive development programme,” said Dr Kemal Malik, member of the Bayer HealthCare Executive Committee, responsible for product development.
“We received it only nine months after the submission – very fast compared to average!
“Rivaroxaban has demonstrated its significant clinical potential in a ground-breaking study programme, 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.”