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November 6, 2011

FDA approves Bayer’s anti-clotting drug

The US Food and Drug Administration (FDA) has approved Bayer Healthcare's anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of a stroke in people with an abnormal heart rhythm (non-valvular atrial fibrillation).

The US Food and Drug Administration (FDA) has approved Bayer Healthcare’s anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of a stroke in people with an abnormal heart rhythm (non-valvular atrial fibrillation).

In clinical trials, the drug, which was co-developed with Johnson & Johnson, was shown to be effective in patients who are at increased risk of stroke due to the presence of co-morbidities such as high blood pressure or diabetes.

Dr Joerg Reinhardt, chairman of the Bayer HealthCare executive committee said, "Today’s approval of rivaroxaban in the US will contribute towards reducing the devastating burden that strokes have on patients and their families."

In atrial fibrillation, the beating of the heart’s two upper heart chambers (atria) is poorly coordinated. This leads to blood pooling in these chambers, resulting in blood clots, and if the flow of blood to a portion of the brain is blocked, a stroke can occur.

The condition occurs in more than two million Americans and is one of the most common types of abnormal heart rhythm, according to the FDA.

Bayer’s shares jumped nearly 5% on today, following the announcement of approval.

Xarelto was also approved by FDA to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism following knee or hip replacement surgery in July this year.

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