Bayer calls a halt to Xarelto trial

Germany’s Bayer and development partner Johnson & Johnson have halted the Phase III NAVIGATE ESUS study of Xarelto (rivaroxaban), saying there’s little chance of showing overall benefit.

The study, which looked at the secondary prevention of stroke and systemic embolism, has been stopped on the recommendation of the independent data monitoring committee.

While bleeding rates were low overall, an increase in bleeding was observed in the rivaroxaban arm compared to the low dose aspirin arm.

The study does not include patients with atrial fibrillation or established atherosclerotic disease. Xarelto is already approved for seven cardiovascular indications.

A complete data analysis is expected to be presented at an upcoming medical meeting in 2018.

Shares in both firms were unaffected.