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Biovitrums and Syntonixs Novel Factor IXFc for Hemophilia B has Received Orphan Drug Designation From the FDA
PharmiWeb, 11/25/08
Biovitrum AB and Syntonix Pharmaceuticals, Inc., a subsidiary of Biogen Idec announced that the company's FIXFc compound for the control and prevention of hemorrhagic episodes in patients with hemophilia B has received an orphan-drug designation from the US Food and Drug Administration (FDA). The FIXFc compound is a recombinant protein in early-stage development for the treatment of hemophilia B, a hereditary bleeding disorder characterized by impaired production of factor IX and the blood's inability to coagulate. The Fc fusion with factor IX is intended to prolong the effect of the compound, the goal being that patients will need less frequent prophylactic treatments than currently existing therapies, which require two to four administrations per week.
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