Coagadex Amended BLA Under Review for Rare Bleeding Disorder

Bio Products Laboratory announced that the Food and Drug Administration (FDA) has accepted for review the amended Biologics License Application (BLA) for Coagadex (coagulation factor X, human) for hereditary X deficiency.

Coagadex is an investigational, high purity human factor X concentrate. Previously the FDA has granted Orphan Drug designation to Coagadex for the treatment of hereditary factor X deficiency. The FDA is currently reviewing data from two Phase 3 trials of Coagadex.

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Currently there are no factor X products specifically approved by the FDA for the treatment of patients with hereditary factor X deficiency.

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