Coagadex Approved for Hereditary Factor X Deficiency

The Food and Drug Administration (FDA) has approved Coagadex (coagulation Factor X [human]; Bio Products Laboratory Limited) for the treatment of hereditary Factor X deficiency in patients aged ≥12 years, the first specific coagulation factor replacement therapy for patients with this condition.

It is indicated for patients that require on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in patients with mild hereditary Factor X deficiency. Coagadex, which is derived from human plasma, was studied in a multi-center, non-randomized study (n=16) that evaluated 208 bleeding episodes for the treatment of spontaneous, traumatic and heavy menstrual bleeding episodes. Coagadex was effective in controlling bleeding episodes in study patients with moderate to severe hereditary Factor X deficiency.

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Coagadex was also studied in 5 patients with mild to severe Factor X deficiency who were undergoing surgery. When the patients received Coagadex for perioperative management for 7 seven surgical procedures, Coagadex was effective in controlling blood loss during and post-surgery. No safety events were identified in both studies.

Coagadex was granted Orphan Drug designation, Fast Track designation, and priority review by the FDA.

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