The US Food and Drug Administration (FDA) has given green signal to drug Savaysa (edoxaban) to lower the risk of stroke and systemic embolism as well as prevent the condition of pulmonary embolism and deep vein thrombosis.
The health regulatory body gave its nod to the drug to treat the patients with atrial fibrillation (not triggered by a heart valve problem) and pulmonary embolism or deep vein thrombosis.
Savaysa is manufactured by the Japanese pharmaceutical firm Daiichi Sankyo. It is based in Tokyo.
The FDA awarded Savaysa a go ahead after it showed promising results during a range of clinical studies where it was compared to warfarin. During the trials, the newly-approved medication was found as effective as warfarin in the prevention of stroke. However, it had prominently fewer cases of serious bleeding episodes that can negatively impact warfarin patients, the FDA said.
On the other hand, bleeding was uncovered as Savaysa’s primary side effect, as was anemia.
According to the reports, the label of the newly-approved Daiichi Sankyo’s drug will carry a boxed warning for the public saying the drug is likely to be less effective among the patients with a creatinine clearance higher than 95 milliliters per minute. In the statutory advisory, the authorities also warn the consumers of high risk of stroke in case of sudden discontinuation of Savaysa drug.