PARSIPPANY, N.J. — Japanese drug maker Daiichi Sankyo is seeking Food and Drug Administration approval for a once-daily tablet to reduce the risk of stroke in patients with atrial fibrillation and treatment of other conditions.
Daiichi Sankyo announced the submission of a new drug application for Savaysa (edoxaban). The company also is hoping to get the FDA's approval for the pill as a treatment for deep vein thrombosis and pulmonary embolism, as well as preventing the recurrence of symptomatic venous thromboembolism.
"The NDA submission in the United States is an important milestone in the development of edoxaban and reflects our long-standing commitment to addressing the needs of patients living with cardiovascular disease, including those living with AF or VTE," said Daiichi Sanko senior executive officer and global head of research and development Glenn Gormley. "If approved, edoxaban may provide a new treatment option for physicians and their patients with these diseases."