U.S. regulators on Thursday approved the use of a drug made by Daiichi Sankyo to reduce the risk of stroke and blood clots in patients with an irregular heartbeat not caused by a heart valve problem.
The new drug, Savaysa, will compete with older blood thinners, including Xarelto, sold by Bayer and Johnson & Johnson, Boehringer Ingelheim's Pradaxa, and Bristol-Myers Squibb's Eliquis.
The Food and Drug Administration said the Daiichi drug is also approved to treat deep vein thrombosis and pulmonary embolism in patients who have already been treated with an anti-clotting drug administered by injection or infusion, for five to ten days.
The agency said that, as with other approved anti-clotting drugs, bleeding, including life-threatening bleeding, is the most serious risk with Savaysa.
Atrial fibrillation affects about 3 million Americans, causing blood to pool in a storage chamber of the heart, where it can clot and travel to the brain.
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