Bayer HealthCare and Janssen apply for new Xarelto indication in US

Bayer HealthCare and its partner Janssen have applied for approval of a new indication of their potential blockbuster drug Xarelto in the US.

The companies have submitted a supplemental new drug application to the US Food and Drug Administration (FDA) for the oral anticoagulant to be used as a means of preventing cardiovascular events in acute coronary syndrome patients, in combination with standard antiplatelet therapy.

This submission is supported by strong data from clinical trials, while Xarelto has previously been given fast track designation by the FDA based on the drug's proven benefits.

It comes after the companies applied to the European Medicines Agency last month for the drug to be approved for secondary prevention after acute coronary syndrome.

Moreover, the treatment was also recently approved as a therapy for deep vein thrombosis and stroke among atrial fibrillation patients in Europe.

Bayer has predicted that Xarelto could generate peak revenues of more than two billion euros (1.67 billion pounds).