FDA OKs new blood thinner to prevent stroke, blood clots in patients with heart condition

Associated Press

The Food and Drug Administration has approved a new blood thinner from a Japanese drugmaker to reduce stroke and blood clots in patients with a common irregular heartbeat.

The agency approved Savaysa tablets late Thursday for patients with atrial fibrillation, a condition in which the heart's upper chambers do not contract properly, which can form dangerous blood clots. The new drug is also approved for patients at risk of deep vein thrombosis and pulmonary embolism who have already been taking anti-clotting drugs.

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Deep vein thrombosis occurs when blood clots form in one of the large, deep veins, usually in the legs. Pulmonary embolism most commonly occurs when part or all of a blood clot travels to the lung, via the heart, where it can partially or completely block the pulmonary artery.

Savaysa enters a crowded field of new blood-thinning drugs, including Boehringer Ingelheim's Pradaxa, Merck & Co. Inc.'s Zontivity, Johnson & Johnson and Bayer Healthcare's Xarelto and Pfizer Inc. and Bristol-Myers Squibb Co.'s Eliquis.

Savaysa was developed by Tokyo-based Daiichi Sankyo Co.

The most common side effects reported in company trials included bleeding and anemia.