The product was evaluated in clinical studies of 16 people with the rare bleeding disorder, which affects people equally. No safety issues were determined in these studies, the FDA said. Coagadex is manufactured by Bio Items Laboratory Ltd., located in the United Kingdom.. Coagadex Approved for Rare Clotting Disorder: – WEDNESDAY, Oct. 21, 2015 – – Coagadex has been authorized by the U.S. Food and Drug Administration as the first coagulation factor replacement therapy for people with a rare bloodstream disorder known as hereditary Factor X insufficiency. The Factor X protein helps blood coagulum. But among people with the inherited disorder, the blood does clot, which can result in dangerous bleeding episodes.The study started in November 2008 with an interesting nationwide campaign. 22 The recruitment period was initiated in June 2009, and the first round finished in June 2011. Ten-year follow-up shall be completed in 2021. The scholarly research protocol was approved by the ethics committee in each hospital, and all subjects provided written informed consent. Study Population Asymptomatic men and women between your ages of 50 and 69 years were eligible for enrollment. Exclusion criteria, that have been ascertained after randomization through a questionnaire at the neighborhood screening office, included a personal history of colorectal malignancy, adenoma, or inflammatory bowel disease; a family group background of hereditary or familial colorectal tumor and sex.