Plasma protein therapies company Bio Products Laboratory Limited (BPL) announced on Wednesday the submission of its supplemental Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for Coagadex for prophylactic treatment of hereditary factor X deficiency.

The company said it has filed its supplemental Biologics License Application (BLA) with the US Food and Drug Administration (FDA) 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, with priority review.

Hereditary factor X deficiency is a rare bleeding disorder and the affected individuals often have inadequate amounts of circulating factor X, an important component of the coagulation system. Factor X deficient patients are at increased risk of bleeding and need to be managed similarly to hemophilia patients.

This supplemental BLA submission is based on the data from the Phase 3 prospective TEN02 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, according to the company.

In conjunction, the primary endpoint of the study was the investigator's assessment of overall efficacy of Coagadex, which was rated as "excellent" by the investigators for all subjects in the per-protocol population. A prophylactic dosing regimen of 40–50 IU/kg twice weekly was recommended in the study. In addition, the safety analysis demonstrates that Coagadex is well-tolerated in this population, concluded the company.