Novel anticoagulant Savaysa gets FDA nod
The novel anticoagulant is indicated to treat deep vein thrombosis and pulmonary embolism and prevent stroke
HealthDay News -- The FDA has approved edoxaban (Savaysa, Daiichi Sankyo) to reduce the risk of stroke and systemic embolism, and prevent deep vein thrombosis and pulmonary embolism.
The drug was approved for people with atrial fibrillation that isn't caused by a heart valve problem, and for people with deep vein thrombosis or pulmonary embolism, the agency said in a press release.
Clinical studies compared edoxaban to warfarin. The newly-approved drug was found as effective as warfarin in preventing stroke, but had significantly fewer cases of major bleeding episodes, the FDA said.
Nonetheless, bleeding was recorded as a primary side effect of edoxaban, as was anemia. The drug's label will include a boxed warning it may be less effective among people with a creatinine clearance greater than 95 milliliters per minute. The advisory also warns that sudden discontinuation of edoxaban increases the risk of stroke.
Edoxaban is made by the Japanese pharmaceutical company Daiichi Sankyo, based in Tokyo.