Drug Development

In a setback, Bayer, J&J say their big PhIII secondary stroke trial for Xarelto failed

Three years after Bayer and J&J began recruiting more than 7,000 patients for a big new Phase III study of Xarelto as preventive measure against a second stroke, researchers are throwing in the towel early, satisfied that their drug can’t beat low-dose aspirin in doing the job.

The blood thinner has proven to be a durable blockbuster for Bayer and J&J, but this attempt to expand their big market flopped. Researchers recruited patients who had experienced a stroke with no clear cause — dubbed an embolic stroke of undetermined source, or ESUS — a big segment of the market.

Joerg Moeller

Not only was there “very little chance of showing overall benefit if the study were completed,” said Bayer, but there was also a higher bleeding rate in the Xarelto arm compared to low dose aspirin.

Just weeks ago the two big pharma partners said they did much better with Xarelto in reducing the risk strokes and heart attacks among patients with severe atherosclerosis. That trial may well open up a new market with tens of millions of patients, worth potentially billions more in revenue.

Bayer had earlier promised to boost revenue on Xarelto to $5.3 billion a year. And even after this setback, they still believe they can do it.

Researchers will now move to shutter this latest study.

“Patients will be contacted by their physician to switch to standard of care, aspirin,” said Joerg Moeller, Bayer’s development chief. “Patients should not stop trial medication without consultation of their physicians. We are committed to continuing the extensive investigation of rivaroxaban for patients at risk of deadly blood clots.”


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