EU CHMP recommends approval of Coagadex (coagulation factor X human) for hereditary factor X deficiency- Bio Products Lab

The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Coagadex (coagulation factor X human), from Bio Products Lab, intended for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency. Coagadex will be available as 250 IU and 500 IU powder and solvent for solution for injection. Coagadex was approvd by the FDA in October 2015.

The CHMP based its recommendation on the results of two non-randomised, open-label, multi-centre studies. Since factor X deficiency is a rare disease the number of participants in these studies was small. 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 demonstrated 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 shown to be effective for the prevention of bleeding during planned surgery. An additional study in children with mild to severe hereditary factor X deficiency is ongoing.