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Savaysa Under-Dosing Not A Concern In DVT/PE Treatment

 
• By Sue Sutter

However, clinical pharmacology and hematology division reviewers differed on whether dose reductions were appropriate for patients of low body weight or using certain concomitant drugs.

Concerns about under-dosing in patients with normal renal function that almost derailed Daiichi Sankyo Inc.’s bid for approval of Savaysa (edoxaban) in atrial fibrillation were a non-issue for the Factor Xa inhibitor’s march toward approval for treatment of venous thromboembolic events.

However, there was disagreement across FDA review divisions as to whether smaller patients with deep vein thrombosis and pulmonary embolism,...

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