Data from Pharmawand - Curated by Toby Galbraith - Date added 14 July 2017
Bio Products Laboratory Limited has presented new data from TEN02, the Phase III, prospective study of Coagadex (Coagulation Factor X, Human) for prophylaxis of bleeding episodes in children below 12 years old with moderate to severe Hereditary Factor X deficiency. Coagadex is currently the only FDA-approved product to treat hereditary factor X deficiency in adults and children older than 12. The primary endpoint of the study was the prophylactic efficacy of Coagadex, which was rated as "excellent" by the investigators for all subjects in the per-protocol population. A dosing regimen of 40–50 IU/kg twice weekly was recommended in the study; dose and frequency were adjusted over the initial six weeks to maintain factor X concentration levels of at least 5 IU/dL (with peak levels ?120 IU/dL). Data from the study showed that Coagadex was effective in preventing bleeding episodes in subjects below 12 years old with moderate to severe factor X deficiency. Consistent with previous findings in subjects of at least 12 years old, Coagadex was well tolerated and safe among subjects below 12 years old.
These new data expand on the established efficacy of Coagadex, which was approved in October 2015 for the treatment of adults and children (aged 12 years and over) with hereditary factor X deficiency for on-demand treatment and control of bleeding episodes, and perioperative management of bleeding in patients with mild hereditary factor X deficiency. Coagadex is the first and only FDA-approved product to treat hereditary factor X deficiency and is the only specific factor X concentrate available in the U.S. These data were presented at the 2017 International Society on Thrombosis and Haemostasis Congress.