US biopharmaceutical company Kedrion Biopharma Inc announced on Tuesday that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Coagulation Factor X human (Coagadex) for the treatment of acquired Factor X Deficiency (aFXD), a rare haematologic disorder with a global prevalence of < 1 in 1,000,000 people.

In addition, the FDA has provided a 'Study may proceed letter' for the initiation of a clinical trial to evaluate the efficacy and safety of Coagadex in treating active bleeding episodes and managing peri-operative bleeding in patients with aFXD associated with AL amyloidosis.

A plasma-derived human coagulation factor concentrate, Coagadex is currently approved in 38 countries for treatment of hereditary Factor X deficiency in adults and children. It is specifically indicated for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding in patients with mild, moderate and severe hereditary Factor X deficiency.

The first trial site will focus on both moderate and severe forms of aFXD, defined by Factor X coagulant activity (FX:C) levels below 50% of normal.

Coagadex is currently approved for the treatment and perioperative management of bleeding episodes in patients with hereditary Factor X deficiency. It is manufactured by Bio Products Laboratory Limited and distributed in the United States by Kedrion Biopharma.