FDA panel recommends against Xarelto approval

An FDA advisory panel Wednesday voted 6-4 against recommending approval of the blood thinning drug Xarelto for use in reducing blood clots.

Janssen Pharmaceuticals, a division of Johnson & Johnson, makes the drug.

The FDA reviewer had recommended approval, but the panel agreed with the reviewer's concerns about internal bleeding and gaps in data from clinical trials.

The FDA does not have to follow panel votes, but usually does.

The drug is already available for other conditions, but approval would have expanded the market for J&J.

— David Sell