Bayer is seeking permission to market in Europe its bloodthinner Xarelto in combination with aspirin to reduce the risk of cardiovascular events in patients with coronary or peripheral artery disease.
The application relates to a low-dose formulation of Xarelto (rivaroxaban 2.5mg) administered twice daily alongside aspirin 100mg once daily, which showed a 24 percent reduction in the combined risk of stroke, cardiovascular death and heart attack in the Phase III Compass trial.
The Compass study also showed that the regimen resulted in a significant reduction in stroke (42 percent) and CV death (22 percent) compared to aspirin 100mg once daily alone.
On the safety side, bleeding incidence rates were low. While there was an increase in major bleeding, there was no significant increase in fatal or intracranial bleeding, Bayer stressed.
If cleared by the European Medicines Agency, low-dose Xarelto plus low-dose aspirin will be the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated for this patient population.
The move comes just days after a lower-dose formulation of the drug was approved by European regulators to prevent recurrent venous thromboembolism.
A filing in the US for the Xarelto/aspirin combination is expected by the end of the year, the firm noted. Bayer markets the Factor Xa inhibitor with Johnson & Johnson.