Bayer HealthCare has applied for European Medicines Agency approval of its oral anticoagulant Xarelto in a new indication.
An application has been filed for the drug to be used in combination with standard antiplatelet therapy for secondary prevention after acute coronary syndrome, making it the first treatment of its kind to be submitted for this specification.
The filing is supported by data from the pivotal global phase III trial Atlas ACS 2-TIMI 51, results from which showed that Xarelto can help improve survival rates compared to antiplatelet therapy alone.
Dr Kemal Malik, head of global development at Bayer HealthCare, said: "The submission of rivaroxaban for secondary prevention after an acute coronary syndrome is a significant milestone for the brand."
This comes after Xarelto was approved by the European Commission earlier this month for the treatment of deep vein thrombosis and stroke among atrial fibrillation patients.
Bayer expects that the therapy will generate multibillion-euro revenues over the coming years.
