Factor X concentrate to treat patients approved by the FDA

Factor X concentrate to treat patients with rare hereditary bleeding disorders approved by the FDA
 

The United States Food and Drug Administration (US FDA) today approved Coagadex, Coagulation Factor X (Human), for hereditary Factor X deficiency. Factor X deficiency is an inherited disorder, affecting men and women equally, where the blood does not clot as it should. The availability of a purified Factor X concentrate increases treatment options for patients with this rare bleeding disorder. The safety and efficacy of Coagadex was evaluated in a multicenter, nonrandomized study involving 16 participants for treatment of spontaneous, traumatic and heavy menstrual bleeding episodes. Coagadex was also evaluated in five participants with mild to severe Factor X deficiency who were undergoing surgery. Coagadex was demonstrated to be effective in controlling bleeding episodes in participants with moderate to severe hereditary Factor X deficiency.
Read the FDA press release