EMA unit recommends approval of Coagadex

The European Medicines Agency ‘s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for Coagadex (human coagulation factor X) to treat factor X deficiency, a rare inherited bleeding disorder.

In Europe, Coagadex is indicated for the treatment and preventive management of bleeding episodes and the control of bleeding during surgical procedures in patients with hereditary factor X deficiency. The medicine’s active substance is human coagulation factor X, a protein derived from human plasma.

Coagadex is produced and marketed by Bio Products Laboratory, a privately-held UK manufacturer of plasma-derived protein therapies, and received US Food and Drug Administration approval last year (The Pharma Letter October 21, 2015).