The U.S. Food and Drug Administration has approved Alprolix, Coagulation Factor IX, Fc Fusion Protein as a treatment option for patients with Hemophilia B.
Alprolix, manufactured by Cambridge, Mass.-based Biogen Idec, helps control and prevent bleeding episodes and manage bleeding during surgery. The drug employs the Factor IX molecule linked to a protein fragment found in antibodies to lengthen its circulation, requiring fewer injections.
Alprolix has been designated an orphan drug, meaning it was developed to treat a specific, rare medical condition. Orphan drug designation qualifies the drug's sponsors for development incentives, such as tax credits for clinical testing, since manufacturers typically will not recover the costs of developing and marketing a treatment drug due to the rarity of the condition.
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