Bayer Rises as Blood Thinner Wins U.S. Panel’s Backing for Heart Condition

http://www.bloomberg.com/news/2011-09-08/j-j-bayer-blood-thinner-wins-u-s-advisers-approval-for-heart-condition.html

Bayer AG (BAYN) rose the most in 10 months in Frankfurt trading after its blood thinner Xarelto won an advisory panel’s support as a treatment to prevent stroke in patients with the most common abnormal heart rhythm.

The drug, known chemically as rivaroxaban, was recommended for atrial fibrillation patients in a 9-2 vote with one abstention by advisers to the Food and Drug Administration meeting yesterday in Adelphi, Maryland. The agency is scheduled to decide whether to approve Xarelto by Nov. 5 and isn’t required to follow the recommendation.

The FDA staff recommended Sept. 6 that the medicine not be cleared for the heart patients because study results didn’t show it would be effective or safe enough. Warfarin, the current standard of care, wasn’t adequately used in a Xarelto study, potentially giving the new treatment from Bayer and partner Johnson & Johnson (JNJ) an unfair advantage, the agency’s staff said in its report.