MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (NYSE:OPK) today announced that the European Committee for Orphan Medicinal Products (COMP) gave a positive opinion recommending the approval of orphan drug designation for OPKO's long-acting version of clotting Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VIII or Factor IX and congenital Factor VII deficiency. These patients are currently being treated by commercially-available Factor VIIa, with estimated 2013 worldwide sales of $1.7 billion. Factor VIIa-CTP already obtained orphan status in the U.S. earlier this year.
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