Bayer said that this decision marks the first approval for Xarelto worldwide. Bayer will start marketing the product immediately.
The approval from Health Canada was based on 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 (Record 1, 2 and 3 trials).
Results from these three studies demonstrated the superior efficacy of Xarelto, both in head-to-head comparisons with enoxaparin (Record 1 and 3), and when comparing extended-duration (five weeks) Xarelto with short-duration (two weeks) enoxaparin (Record 2). In all three trials, Xarelto and enoxaparin had similar safety profiles including low rates of major bleeding.
Xarelto has also been recommended for approval by the European Committee for Medicinal Products for Human Use and Bayer expects the marketing authorization across all EU-member states very soon.
Arthur Higgins, CEO of Bayer HealthCare, said: “Xarelto, discovered in Bayer’s Wuppertal laboratories in Germany, is a first-in-class product and the only oral anticoagulant to demonstrate superior efficacy over the standard of care, enoxaparin.
“The approval in Canada marks an important milestone for the most extensively studied product of its class and Bayer HealthCare has achieved a major step forward in establishing a new era in antithrombosis therapy.”