First coagulation therapy sanctioned for Factor X deficiency
WEDNESDAY, Oct. 21, 2015 (HealthDay News) — Coagadex (coagulation Factor X) has been approved by the U.S. Food and Drug Administration as the first coagulation factor replacement therapy for people with a rare blood disorder known as hereditary Factor X deficiency.
Coagadex, derived from human blood plasma, has been approved for people 12 years and older to control and prevent random bleeding episodes, and those stemming from menstruation or recent surgery.
The product was evaluated in clinical studies of 16 patients with moderate to severe hereditary Factor X deficiency, and demonstrated efficacy in controlling bleeding episodes. No safety concerns were identified in these studies, the FDA said.
“The approval of Coagadex is a significant advancement for patients who suffer from this rare but serious disease,” Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
Coagadex is manufactured by Bio Products Laboratory Ltd., based in the United Kingdom.