Bayer files for EU approval of Xarelto in artery disease

Bayer has filed for European regulatory approval of its anticoagulant Xarelto in a new heart disease indication.

An application has been submitted to the European Medicines Agency for the marketing authorisation of a vascular dose of the rivaroxaban Factor Xa inhibitor therapy, in combination with aspirin, for the treatment of coronary artery disease and peripheral artery disease.

This submission is supported by the results of the phase III COMPASS study, which has shown that a vascular dose of Xarelto plus aspirin can reduce the risk of stroke, cardiovascular death and heart attack by an unprecedented 24 percent compared with aspirin alone.

Given that cardiovascular disease is responsible for around 17.7 million deaths every year – or 31 percent of all global deaths – there remains a strong need for new therapeutic options.

Dr Joerg Moeller, member of the executive committee of Bayer's pharmaceutical division and head of development, said: "With rivaroxaban, we have a medicine that has already helped millions of patients and we look forward to bringing this treatment option to many more patients in the future."

Bayer is also expecting to file a similar submission with the US Food and Drug Administration before the end of the year.

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