FDA approves first Factor X concentrate for rare hereditary bleeding disorder

The US Food and Drug Administration yesterday approved Coagadex, coagulation Factor X (human), for hereditary Factor X (10) deficiency.

Until this orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency. Coagadex is produced and marketed by Bio Products Laboratory, a privately-held UK manufacturer of plasma-derived protein therapies.

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