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Posted 2 Feb 2016 by Drugs.com
WEDNESDAY, Oct. 21, 2015 – 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. The Factor X protein normally helps blood clot. But among people with the inherited disorder, the blood doesn't clot, which can lead to dangerous bleeding episodes. Traditional treatments are based on plasma-derived products containing vitamin K-dependent proteins to stem or prevent bleeding, the agency said in a news release. 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 people with the rare bleeding disorder, which affects men and women ... Read more
Posted 21 Oct 2015 by Drugs.com
October 20, 2015 – The U.S. Food and Drug Administration today approved Coagadex, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Until today’s orphan drug approval, 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. Patients with the disorder are usually treated with fresh-frozen plasma or plasma-derived prothrombin complex concentrates (plasma products containing a combination of vitamin K-dependent proteins) to stop or prevent bleeding. The availability of a purified Factor X concentrate increases treatment options for patients with this rare bleeding disorder. “The ... Read more