Posted by Michael Wonder on 24 May 2018
FDA accepts supplemental biologics license application and grants priority review for prophylactic and paediatric use for Bio Products Laboratory's Coagadex (coagulation factor X, human) for treatment of hereditary factor X deficiency
23 May 2018 - FDA previously granted Coagadex orphan drug designation for the treatment of hereditary factor X deficiency.
Bio Products Laboratory Limited announced today that the U.S. FDA has accepted for filing a supplemental biologics license application for Coagadex (coagulation factor X, human) for prophylactic treatment of hereditary factor X deficiency, as well as treatment in children under 12 years of age.
The submission of the supplemental application is based on data from TEN02, the Phase 3 prospective study of Coagade (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 peri-operative 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.
