Jan 14 (Reuters) – The U.S. Food and Drug Administration appears skeptical that data submitted by Johnson & Johnson proves its anticoagulant Xarelto is effective in reducing the risk of further heart problems in patients who have recently suffered a heart attack.
The agency questioned the way in which J&J analyzed clinical trial data, and said there was no convincing proof the drug confers significant benefit or fills an unmet medical need, given that there are other therapies on the market.
