Bayer’s Novel Anticoagulant Xarelto now also Approved in the EU

10-02-2008: The Bayer Group has achieved a major success in its product development: The European Commission has granted marketing approval for Xarelto® (rivaroxaban), a novel anticoagulant taken as one tablet, once-daily, for the prevention of venous blood clots in adult patients undergoing elective (planned) hip or knee replacement surgery. Bayer HealthCare will start launching the product in the EU member states very soon.

“The successful development program of Xarelto underpins Bayer’s innovative strength,” said Werner Wenning, CEO of Bayer AG. “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.”

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.

“Venous blood clots kill more than half a million people a year in the EU,” commented Dr. Bengt Eriksson, Orthopedic Surgeon at the Sahlgrenska University Hospital/Östra, Gothenburg, Sweden, and a leading investigator in the Xarelto clinical development program. “Existing treatments have limitations in terms of efficacy and ease of administration. The development of Xarelto, an effective oral, once-daily anticoagulant, which does not need routine coagulation monitoring, is a huge step forward in blood clot prevention, and will save lives.”

On September 15, 2008, Health Canada granted Bayer HealthCare marketing authorization for the novel anticoagulant Xarelto. Taken as one tablet, once-daily, it was approved for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or total knee replacement surgery. This decision marked the first approval for Xarelto worldwide. Bayer started marketing the product in Canada immediately.

Xarelto was submitted in July 2008 for approval to the U.S. Food and Drug Administration (FDA). On approval, Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market the drug in the United States. In addition to the FDA submission, filings are under review with regulatory agencies in more than 10 other countries.

Almost 50,000 patients are expected to be enrolled into the extensive development program with Xarelto worldwide. The clinical trial program will evaluate the product in the prevention and treatment of a broad range of acute and chronic blood-clotting disorders including VTE treatment, stroke prevention in patients with atrial fibrillation, VTE prevention in hospitalized, medically ill patients, and secondary prevention of acute coronary syndrome.

Xarelto 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.