Compliance Management / Large Molecule

FDA Approves Coagadex for Rare Bleeding Disorder

Oct 21, 2015

The U.S. Food and Drug Administration announced the approval of Coagadex, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Until today’s orphan drug approval, FDA says 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 the blood does not clot as it should.

“The approval of Coagadex is a significant advancement for patients who suffer from this rare but serious disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Coagadex, which is derived from human plasma, is indicated for individuals age 12 and older with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes, and for perioperative (period extending from the time of hospitalization for surgery to the time of discharge) management of bleeding in patients with mild hereditary Factor X deficiency.

Coagadex is manufactured by Bio Products Laboratory Limited in Elstree, Hertfordshire, United Kingdom.