EMA recommends approval of Coagadex to treat rare bleeding disorder

In Europe, Coagadex (human coagulation factor X) 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.

Human coagulation factor X, a protein derived from human plasma, is the medicine’s active substance.

The disorder occurs due to the insufficient factor X, which is required for the blood coagulation (clotting) process.

The EMA’s recommendation was based on the results of two non-randomized, open-label, multi-center trials.

The number of participants in the trials was small since factor X deficiency is a rare disease.

A phase III study evaluated the treatment of a total of 207 spontaneous bleeds in 16 patients with moderate or severe factor X deficiency and showed an effective response, excellent or good in 98.8% of the bleeds treated.

Five patients participating in the study underwent seven surgical procedures and Coagadex was also demonstrated to be effective in avoiding bleeding during planned surgery.

A further study in children with mild to severe hereditary factor X deficiency is ongoing.

UK-based Bio Products Laboratory (BPL) produces and markets Coagadex, which secured approval from the US Food and Drug Administration in 2015.

BPL has been involved in the processing of human plasma since 1950 when it was initially established as part of the Lister Institute by the Medical Research Council, and

The company began manufacturing specific immunoglobulins in 1972 and opened a £60m production facility in 1987.