FRANKFURT/BERLIN (Reuters) - Bayer stood by its peak sales estimate for clot prevention drug Xarelto after the pill disappointed in a late-stage trial to test prevention of repeat strokes.
The Phase III study had been halted early after the drug showed no efficacy improvements over low-dose aspirin, Bayer said in a statement late on Thursday.
The German drugmaker last year raised its annual peak sales estimate for Xarelto to more than 5 billion euros ($5.3 billion).
The study was evaluating the efficacy and safety of Xarelto, also known as rivaroxaban, for the secondary prevention of stroke and systemic embolism in patients with a recent embolic stroke of undetermined source.
“While bleeding rates were low overall, an increase in bleeding was observed in the rivaroxaban arm compared to the low dose aspirin arm,” Bayer said in its statement.
The drug is already approved for a number of cardiovascular conditions and prevention of strokes caused by a type of irregular heart beat common among the elderly is the main profit driver.
Earlier this year, a successful trial on the prevention of potentially deadly strokes and heart attacks in patients with severe atherosclerosis raised the prospect of billions more in sales.
Xarelto was jointly developed by Bayer and Johnson & Johnson, which owns the U.S. rights to the drug.
Bayer said the trial has no bearing on the positive benefits of Xarelto for other uses for which it is currently licensed.
Reporting by Victoria Bryan and Ludwig Burger; Editing by Muralikumar Anantharaman and Keith Weir