CHMP Recommends Coagadex for Factor X Deficiency

Miriam E. Tucker

January 29, 2016

The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of an antihemorrhagic factor X concentrate (Coagadex, Bio Products Laboratory Limited) for treatment, prophylaxis, and perioperative management in patients with hereditary factor X deficiency.

The injectable product, which was designated as an orphan medicinal product in 2007 and evaluated under accelerated assessment, will be available as 250 IU and 500 IU powder and solvent for solution.

By temporarily raising plasma levels of factor X, the product has the ability both to stop bleeding when given on demand and to prevent bleeding when used as routine prophylaxis or for surgical procedures.

The most common adverse effects are back pain, redness or pain at the site of the infusion, and tiredness.

Factor X should be prescribed by physicians experienced in the treatment of rare bleeding disorders, the CHMP suggests.

Detailed recommendations for the use of the product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after marketing authorization has been granted by the European Commission.

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