FDA accepts sBLA for Coagadex in hereditary factor X deficiency.- Bio Products Lab.

The FDA has accepted for filing a supplemental Biologics License Application (BLA) for Coagadex (Coagulation Factor X, Human), from Bio Products Laboratory, for prophylactic treatment of hereditary factor X deficiency, as well as treatment in children under 12 years of age.

The submission of the supplemental BLA is based on data from TEN02, the Phase III prospective study of Coagadex (Coagulation Factor X, Human) for prophylaxis of bleeding episodes in children under 12 years old with moderate to severe hereditary factor X deficiency.

Coagadex was first 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.