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February 28, 2014
09:59 EDTOPKOPKO Health confirms orphan designation for longer-acting Factor VIIa-CTP
OPKO Health announced that the U.S. Food and Drug Administration has granted orphan drug designation to OPKO's longer-acting version of clotting Factor VIIa for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VIII or Factor IX. Currently, Factor VIIa therapy is available only as an intravenous formulation, OPKO said. OPKO CEO Phil Frost said, "Expecting to initiate a Phase IIa trial with our IV formulation in hemophilia patients in late 2014, we believe that we are in a unique position to be first to market with a longer acting Factor VIIa product.
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