FDA Approves Corifact to Treat Congenital FXIII Deficiency
- By BSTQ Staff
The U.S. Food and DrugAdministration has granted marketing approval for Corifact Factor XIII Concentrate (Human) for the routine prophylactic treatment of congenital factor XIII (FXIII) deficiency. Manufactured by CSL Behring, Corifact, already available in 12 countries throughout the world under the trade name Fibrogammin-P, is the first and only FXIII concentrate approved in the U.S.
Congenital FXIII deficiency, also known as fibrin-stabilizing factor deficiency, is a rare and potentially lifethreatening bleeding disorder in which blood clots normally, but the clots formed are unstable, leading to recurrent bleeding. An estimated 150, or one in every two million people, are affected by the condition.