EMA approves Coagadex (coagulation factor X human) to treat hereditary factor X deficiency.- Bio Products Ltd

Bio Products Laboratory, Limited has announced that the European Medicines Agency has granted marketing authorisation for Coagadex. Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency. Coagadex is the first and only treatment licensed specifically for this rare bleeding disorder in Europe. Factor X deficiency is a rare and serious condition caused by not having enough of the Factor X protein in the blood; this protein plays a crucial role in coagulation (blood clotting) which helps patients stop bleeding.

People with Factor X deficiency are at increased risk of bleeding or experience excessive or prolonged bleeding. Severely affected individuals, usually children, have an increased risk of bleeding inside the brain, in the lungs or in the gastrointestinal tract, which can be life-threatening. Hereditary Factor X deficiency is very rare and affects approximately 700 patients in Europe.