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news.The Bayer Group has announced that the European Commission has granted marketing approval for Xarelto, a novel anticoagulant taken as one tablet, once-daily, for the prevention of venous blood clots in adult patients undergoing elective hip or knee replacement surgery. Bayer HealthCare will start launching the product in the EU member states soon.
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EU marketing approval for Xarelto was received following a review of data from the extensive record clinical program that included three Phase III trials of Xarelto 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 Xarelto, both in head-to-head comparisons with enoxaparin (Record1 and 3) as well as when comparing extended-duration (5 weeks) Xarelto with short-duration (2 weeks) enoxaparin (Record2). In all three trials, Xarelto and enoxaparin had comparable safety profiles including low rates of major bleeding.
Xarelto was also submitted for approval to the FDA. On approval, Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, will market the drug in the US. In addition to the FDA submission, filings are under review with regulatory agencies in more than 10 other countries, the company said.
Xarelto was invented in Bayer’s Wuppertal laboratories in Germany, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development.
Werner Wenning, CEO of Bayer, said: “The successful development program of Xarelto underpins Bayer’s innovative strength. Xarelto could prove to be a significant medical breakthrough, bringing hope to millions of patients worldwide. As Xarelto has the potential to become a blockbuster, its launch is an important milestone for Bayer.”