rivaroxaban

J&J, Bayer report Phase II Xarelto data

Maureen Martino — Mon, 10 Nov 2008 12:15:07 -0500

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
- see the report for more

CHMP recommends Bayer's Xarelto

Maureen Martino — Fri, 25 Jul 2008 11:35:46 -0400

CHMP announced today the recommendation of Bayer's Xarelto, known generically as rivaroxaban. Xarelto, a blood-thinning pill to prevent clots in patients bedridden after major orthopedic surgery, is being developed jointly with J&J in the U.S. The companies recently announced the results of a study in which rivaroxaban was better than Sanofi's blockbuster Lovenox in preventing venous blood clots in knee replacement patients. The drug is one of Bayer's great pipeline hopes, and could have sales exceeding €2 billion in Europe if approved there.

"The recommendation for approval of rivaroxaban by the CHMP marks another significant milestone in our extensive development program. We received it only nine months after the submission--very fast compared to average," said Dr. Kemal Malik, a member of the Bayer HealthCare Executive Committee. Final approval of the drug is expected in the next several months.

- see Bayer's release
- read this report form Forbes

Bayer, J&J tout rivaroxaban data

Fri, 30 May 2008 06:59:58 -0400

In a head-to-head study against Sanofi's Lovenox, Bayer and J&J's oral anti-clotting drug rivaroxaban proved superior in preventing venous blood clots in patients who underwent total knee replacement surgery. Lovenox, which is the current standard of care, is given twice daily. "Only 6.9 percent of patients treated with Rivaroxaban experienced thomboembolisms, compared with 10.1 percent for the comparison group...This reflects a 31 percent decrease in relative risk," noted Dow Jones. This was the third trial to demonstrate the drug's superiority over Lovenox. An NDA is planned for the third quarter of this year. The drug is also being developed for stroke prevention in atrial fibrillation and VTE treatment.

- see the rivaroxaban release
- here's the Dow Jones brief