Bayer rises 9% as FDA panel recommends Xarelto for post-surgery VTE prevention

29 March 2009

An expert panel convened by the US Food and Drug Administration has recommended Bayer's Xarelto (rivaroxaban) for approval. Shares in the  German drug major rose as much as 9% in morning trading after the news  on March 20.

Developed with US health major Johnson & Johnson, the once-daily  anticoagulant was given the go-ahead as a treatment for the prevention  of deep vein thrombosis and pulmonary embolism in patients undergoing  hip or knee replacement surgery.

The members of an advisory committee to the FDA voted 15 to two that  "available clinical data demonstrated a favorable risk-benefit  profile." The recommendation reverses negative sentiment a few days  before the meeting, which saw shares in Bayer fall 10% to 32.69 euros on  March 17, after documents were posted on the FDA's web site stating that  Xarelto carries a high risk of internal bleeding.

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