First Factor X Deficiency Bleeding Disorder Therapy Is Approved
- By BSTQ Staff
In October, the U.S. Food and Drug Administration approved the first replacement therapy for hereditary factor X deficiency, coagulation factor X (Coagadex, Bio Products Laboratory), derived from human plasma. Coagadex is approved for individuals 12 years and older for on-demand treatment control of bleeding episodes, as well as for perioperative management of bleeding in individuals with mild hereditary factor X deficiency. Factor X deficiency affects men and women equally. Prior to the approval of Coagadex, patients were generally treated with fresh frozen plasma or plasma-derived prothrombin complex concentrates; there was no specific coagulation factor replacement therapy available for patients with hereditary factor X deficiency.
