Bayer HealthCare applies for approval of new Xarelto indications

Bayer HealthCare is applying for marketing authorisation of its drug Xarelto in several new indications.

The company is seeking European Medicines Agency approval for the rivaroxaban-based oral anticoagulant as a therapy for stroke prevention in atrial fibrillation sufferers, as well as for treating and preventing recurrent deep vein thrombosis (DVT) and pulmonary embolisms (PE).

This submission is based on positive clinical trial data from three recent phase III studies that demonstrate the drug's efficacy in these indications.

Xarelto was developed in association with Johnson and Johnson Pharmaceuticals and has been approved for venous thromboembolism prevention among hip or knee replacement surgery patients in more than 100 countries.

Bayer HealthCare and Johnson and Johnson are also currently seeking US approval for the drug as a treatment for DVT and PE.

Last month, Bayer HealthCare published positive trial data for VEGF Trap-Eye, its promising new treatment for eye diseases and disorders.