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Europe Grants Licensure for Ceprotin (Protein C Concentrate) For Treatment of Protein C Deficiency

BRUSSELS, BELGIUM -- July 19, 2001 -- The European Medicines Evaluation Agency has granted licensure for Ceprotin, protein C concentrate, as a replacement therapy for people with life-threatening blood clotting complications related to severe congenital protein C deficiency.

Baxter is the first company to receive a license using the European centralized procedure, a process by which the European Commission grants authorization that is valid in all member states of the European Union.

Protein C is a component in human plasma that regulates the coagulation system and prevents abnormal clot formation (thrombosis). Currently, there is no ideal alternative to specific protein C replacement therapy. Protein C may be replaced with fresh frozen plasma, but this involves infusing patients with very large volumes of plasma, which can result in fluid overload, causing pulmonary edema and hypertension. Other treatment approaches, such as oral anticoagulation, are associated with a risk of bleeding as well as inadequate control of the serious and widespread thrombotic disorder.

The incidence of severe hereditary protein C deficiency is approximately one in every 200,000 births, and often goes undiagnosed. If left untreated, the thrombotic lesions that develop can result in blindness, severe brain damage, multi-organ failure, and death. Baxter intends to initiate clinical trials in acquired protein C deficiency in the near future.


SOURCE: Baxter International, Inc.

Related Link: Baxter International, Inc.

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