Bayer HealthCare and Johnson & Johnson have good news to present about their blood-thinner Xarelto--a potential blockbuster that the FDA declined to approve months ago. Results from a long-term clinical trial showed taking Xarelto led to an 82 percent lower risk that a venous blood clot would form again compared with placebo, according to a Reuters article.
The Phase III EINSTEIN-extension study followed roughly 1,200 patients who had suffered a thrombosis and undergone six or 12 months of anticoagulant therapy, Bayer says in a statement. Patients in the study received either once-daily Xarelto or a placebo for another six to 12 months. Bayer said more "promising" detailed results from the study will be presented at an American Society of Hematology conference Dec. 8.
The FDA issued a complete response letter for Xarelto [1] in May that asked for more data on the therapy. The companies did not detail exactly what additional information the FDA requested. Xarelto is approved to treat venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery in more than 80 countries, including Australia, Canada, China and Mexico.
- read the Reuters coverage [2]
- check out the Bayer release [3]
Related Articles:
FDA asks for more data on Xarelto [1]
Bayer shares soar as FDA panel backs Xarelto [4]
Links:
[1] http://www.fiercebiotech.com/story/fda-asks-more-data-bayer-j-js-xarelto/2009-05-28
[2] http://www.reuters.com/article/rbssPharmaceuticals%20-%20Diversified/idUSLJ65560620091119
[3] http://www.fiercebiotech.com/press-releases/positive-results-chronic-study-bayers-rivaroxaban-will-be-presented-late-breaker-ash-
[4] http://www.fiercebiotech.com/story/bayer-shares-soar-fda-panel-backs-xarelto/2009-03-20