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news.Bayer HealthCare, a subsidiary of Bayer AG, has announced that the European Committee for Medicinal Products for Human Use has recommended approval of the anticoagulant rivaroxaban, taken as one tablet, once-daily, for the prevention of venous blood clots in patients undergoing elective hip or knee replacement surgery.
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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.
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.
Results from these three studies demonstrated the superior efficacy of rivaroxaban, both in head-to-head comparisons with enoxaparin, and when comparing extended-duration (five weeks) rivaroxaban with short-duration (two weeks) enoxaparin (Record 2). In all three trials, rivaroxaban and enoxaparin had comparable safety profiles including similar low rates of major bleeding.
Rivaroxaban was invented in Bayer’s Wuppertal laboratories in Germany, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development.
Rivaroxaban is expected to be filed for approval in the US shortly, and on approval, Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, will market the drug in the US.