J&J, Bayer report Phase II Xarelto data

Bayer and Johnson & Johnson's presented results from a Phase II study of experimental anti-clotting drug Xarelto (rivaroxaban) at the American Heart Association's annual meeting. The dose-finding study tested the safety and efficacy of rivaroxaban ranging from 5 mg up to 20 mg administered at once-daily and twice-daily intervals. Researchers said the 2.5 mg and 5 mg doses achieved the best balance between efficacy and safety.

In the study, rivaroxaban was found to cut heart attacks by 31 percent in patients taking aspirin and in some cases Plavix. But subjects on higher doses of Xarelto experienced higher rates of bleeding versus placebo. Though most of the bleeding events were mild, 1.2 percent were characterized as very serious episodes.

The companies said the study results support moving rivaroxaban into a pivotal Phase III trial for the secondary prevention of acute coronary syndrome later this year

- here's the release [1]
- see the report [2] for more

Related Articles:
CHMP recommends Bayer's Xarelto [3]
Bayer, J&J tout rivaroxaban data [4]