Bayer to present phase II rivaroxaban data

Bayer HealthCare has announced plans to present phase II clinical trial data for Xaelto (rivaroxaban) at the upcoming annual meeting American Heart Association this November.

The company said the presentation of the results shows the development of Xarelto have taken another step forward.

In the Atlas ACS Timi 46 Trial, around 3,500 patients were treated in the large dose-finding trial.

Bayer said it planned the acceleration of clinical development of the compound in patients with acute coronary syndrome.

Together with its co-development partners Johnson & Johnson Pharmaceutical Research & Development, the company will initiate phase III clinical trials for the compound ahead of the previously forecast date of the second half of 2009.

“The extensive clinical trial evidence supporting rivaroxaban makes it the most studied oral direct Factor Xa inhibitor in the world today,” Bayer said.

It added nearly 50,000 patients will eventually be enrolled into the clinical development programme for rivaroxaban to evaluate the compound for the prevention and treatment of venous thromboembolism, stroke prevention in patients with atrial fibrillation and other chronic blood-clotting disorders.

Last month, Bayer announced Xarelto has been recommended for approval in the European Union for the prevention of venous blood clots in elective knee or hip replacement surgery patients.