Small Molecule / Compliance Management

FDA Gives Nod to Anti-clotting Drug Savaysa

Jan 12, 2015

The U.S. Food and Drug Administration approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

Savaysa also has been approved to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an anti-clotting drug administered by injection or infusion (parenterally), for five to ten days.

“In patients with atrial fibrillation, anti-clotting drugs lower the risk of stroke by helping to prevent blood clots from forming in the heart,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of these types of drugs available as options for patients.”

Savaysa is made by Tokyo-based Daiichi Sankyo Co., Ltd.

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