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FDA Grants Priority Review for New Uses of Anticlotting Drug Xarelto
DVT is a condition in which blood clots form in one of the large, deep veins, usually in the legs. PE is a serious condition that most commonly occurs when part or all of a DVT dislodges and is carried to the lungs, via the heart, where it can partially or completely block a branch of the pulmonary artery.
Under the Prescription Drug User Fee Act (PDUFA), the FDA will aim to complete its review within 6 months from the receipt of the sNDA submission, rather than the standard 10-month review cycle.
The submissions are supported by data from the global EINSTEIN program, which includes two Phase III studies that evaluated the safety and efficacy of rivaroxaban in the treatment of patients with acute symptomatic DVT or PE and the prevention of recurrent events in these patients. A third Phase III trial evaluated the safety and efficacy of rivaroxaban in the long-term prevention of recurrent DVT and PE. The three studies included a total of more than 9,400 patients.
Read the news release here.