Baxter gets EU approval for Ceprotin

The European Medicines Evaluation Agency has approved of BaxterInternational's monoclonal antibody Ceprotin (vapor-heated protein C concentrate) for use as a replacement therapy for patients suffering from life-threatening blood-clotting complications related to severe congenital protein C deficiency.

Protein C is a component in human plasma that regulates the coagulation system and prevents thrombosis. There are two types of protein C deficiency; homozygous and heterozygous. The former is characterized by purpura fulminans, venous thrombosis and/or pulmonary embolism, and the latter is associated with the development of severe, and often fatal, purpura fulminans and disseminated intravascular coagulation during the neonatal period.

Last year, Baxter announced trial data which demonstrated that Ceprotin is a safe and effective treatment for severe congenital protein C deficiency with or without purpura fulminans. The drug was tested for its ability to treat acute symptoms and for prophylaxis, and the regression of skin lesions and dissolution of thrombotic occlusions were assessed. According to Barbara Moritz of Baxter Hyland Immuno in Vienna, Austria, of the 43 treatment courses, 35 were rated by investigators as excellent and six as good.