FDA Approves First Factor X Concentrate to Treat Patients with Rare Hereditary Bleeding Disorder

Silver Spring, Maryland–(ENEWSPF)–October 20, 2015. The U.S. Food and Drug Administration today approved Coagadex, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Until today’s orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency.

In healthy individuals, the Factor X protein activates enzymes to help with normal blood clotting in the body. Factor X deficiency is an inherited disorder, affecting men and women equally, where…