Xarelto (rivaroxaban) has been granted EU marketing approval for the prevention of venous blood clots in adult patients undergoing elective hip or knee replacement surgery.
The novel antocoagulant – which is taken as one tablet, once daily – is a product of the Beyer Group and will be launched in the EU very soon.
Werner Wenning, CEO of Bayer AG commented on the approval: “The successful development programme of Xarelto underpins Bayer’s innovative strength. Xarelto could prove to be a significant medical breakthrough, bringing hope to millions of patients worldwide,” he said.
“As Xarelto has the potential to become a blockbuster, its launch is an important milestone for Bayer.”
The approval comes after data was reviewd following an extensive RECORD clinical programme including three phase III trials of the product involving nearly 10,000 participants undergoing elective hip or knee replacement surgery.
Xarelto demonstrated superior efficacy, both in head-to-head comparisons with enoxaparin, as well as when comparing extended-duration (5 weeks) Xarelto with short-duration enoxaparin.
Dr Bengt Eriksson, Orthopedic Surgeon at the Sahlgrenska University Hospital/Östra, Gothenburg, Sweden, and a leading investigator in the Xarelto clinical development programme commented: “Venous blood clots kill more than half a million people a year in the EU. 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.”