Janssen reports positive real-world safety data for Xarelto

Janssen has announced data from a real-world post-marketing study that demonstrates the safety of Xarelto, the novel oral anticoagulant it has developed in partnership with Bayer HealthCare.

Researchers analysed data from January 1st 2013 to March 31st 2014, using US Department of Defense integrated electronic healthcare records, to examine the safety performance of once-daily Xarelto in patients with non-valvular atrial fibrillation.

It was shown that rates and patterns of major bleeding in routine clinical practice are generally consistent with those observed in the phase III clinical trials used to support regulatory approval for the medicine in this indication.

These are the initial findings from an ongoing five-year observational study of patients using Xarelto daily over the course of their lives, with further insights yet to come.

Dr Paul Burton, vice-president of medical affairs at Janssen, said: "After more than three years on the market and more than ten million patients prescribed, we continue to monitor the safety performance of our medicine."

This comes after Janssen and Bayer launched three new studies last September assessing the safety and efficacy of Xarelto in the prevention of blood clots among patients at risk of arterial thromboembolism.