Bayer shares sink on FDA staff's Xarelto review

Shares of Bayer AG were badly dented this morning after the FDA released staffers' critical remarks on Xarelto, a blood clot drug that will be reviewed by an expert committee on Thursday.

Widely seen as a prospective blockbuster, the FDA staff review noted that the drug--also known by the generic name rivaroxaban--was better than a comparative drug at preventing blood clots but increased bleeding among the patient staking the therapy in clinical trials. The risk of ‘major bleeding'--meaning it required medical intervention--was relatively low overall but still twice the rate seen among patients taking enoxaparin. And staffers also noted elevated liver enzymes indicative of liver damage and called for long-term safety data to evaluate the issue.

Bayer shares dropped slightly more than six percent on the news. If approved, Johnson & Johnson would be responsible for marketing the drug in the U.S. In a document posted by the FDA, J&J said that Xarelto had a "favorable safety profile." A number of analysts have been betting on an FDA approval for Xarelto, which would compete with Lovenox.

- read the report from Dow Jones

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