FDA staff cautious about J&J's latest Xarelto application

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FDA staff cautious about J&J's latest Xarelto application

By Toni Clarke WASHINGTON (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. The review was posted on the FDA's website on Tuesday, two days ahead of a meeting of outside experts who will discuss the drug, also known as rivaroxaban, and recommend whether it should be approved. Xarelto is already used to treat and prevent deep vein thrombosis and pulmonary embolisms and to reduce the risk of stroke and blood clots in patients with an irregular heart beat that is not caused by heart problems.

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