Anti-clotting drug Savaysa gets FDA aopproval

Savaysa (edoxaban) has been approved by the Food and Drug Administration (FDA) to reduce the risk of stroke and blood clots in patients with atrial fibrillation not caused by a heart valve problem.

Savaysa can also be used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with anti-clotting drugs for five to 10 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,” FDA Center for Drug Evaluation and Research Division of Cardiovascular and Renal Products Director Norman Stockbridge said. “It is important to have a variety of these types of drugs available as options for patients.”

A clinical trial with 21,105 participants with atrial fibrillation not caused by cardiac valve disease was conducted. Two dose levels were tested against the anti-clotting drug warfarin. The higher dose of Savaysa tested was comparable to warfarin. However, Savaysa caused less bleeding that warfarin.

A study was also done on 8,292 patients with DVT and PE comparing Savaysa to warfarin. In the study, 3.2 percent of participants had a recurrent symptomatic venous thromboembolism when treated with Savaysa as compared with 3.5 percent of recurrence when treated with warfarin.

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